Apparatus and method for septal punch

ABSTRACT

In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/858,015, filed Apr. 24, 2020, entitled “Apparatus and Method forSeptal Punch,” which is a continuation-in-part of InternationalApplication No. PCT/US2019/052714, filed Sep. 24, 2019, entitled“Apparatus and Method for Septal Punch,” which claims priority to U.S.Provisional Application No. 62/735,410, filed Sep. 24, 2018, entitled“Device for Transseptal Puncture,” the disclosures of each of which arehereby incorporated by reference in their entirety.

U.S. application Ser. No. 16/858,015 also claims priority to and thebenefit of U.S. Provisional Application No. 62/994,751, filed Mar. 25,2020, entitled “Apparatus and Method for Septal Punch,” the disclosuresof which is hereby incorporated by reference in its entirety.

BACKGROUND

Embodiments are described herein that relate to devices and methods foruse in accessing the left side of the heart.

Many diseases and disorders, such as, for example, heart failure, atrialfibrillation, mitral valve disease, and others, specifically impact orare addressable in the left side of the heart. Accordingly, manyinterventional percutaneous cardiac procedures require access to theleft side of the heart, including, for example, electrophysiologicalprocedures, left atrial appendage occlusion procedures, mitral valverepair and replacement procedures, atrial shunt procedures, and manymore. In additional to therapeutic interventional procedures,indications for access to the left side of the heart also includediagnostic procedures, including, for example, hemodynamic measurements(e.g., left atrial pressure, trans-mitral pressure gradient, etc.).Minimally-invasive access to the left side of the heart is challengingand not without significant risk.

Some catheter-based procedures access the left side of the heart bypuncturing the atrial septum (“AS”) of the heart, which separates theleft atrium (“LA”) of the heart from the right atrium (“RA”) of theheart. Such procedures use a catheter containing a sheathed needle,which is advanced from the femoral vein in the groin of the patient tothe superior vena cava (“SVC”) through the RA of the heart. The sheathedneedle is often a long, stiff-wire needle that has a bend ofapproximately twenty degrees near its tip. With the catheter assemblydisposed within the SVC, the catheter assembly is then slowly withdrawninferiorly from the SVC and into the RA until its tip rests within thefossa ovalis (“fossa”, “FO”, or “F”). The FO is a thumbprint-sizeddepression in the wall of the RA, and is the thinnest portion of theinteratrial septum (i.e., the wall between the RA and LA). Once theoperator visualizes contact between the tip of the catheter assembly andthe F, the needle is advanced such that it punctures the F. With theneedle extending from the LA into the RA, a guidewire is advancedthrough the catheter and into the RA. The needle is then removed fromthe LA, and a device (e.g., an AF ablation device, a catheter,percutaneous mitral valve repair delivery system or catheter, asexamples) can be inserted into the LA.

Alternative procedures include the use of a blunt needle, electrified byradiofrequency, to puncture or perforate the atrial septum.

The above procedure has significant limitations. It is difficult tolearn, time intensive, and prone to premature, misaligned, andinadvertent puncturing of the FO. Further, precisely and accuratelylocating the F with the tip of the device is difficult, and if thecatheter assembly is withdrawn from the SVC too far, time-intensiveprocedural steps must be repeated because such a device cannot be movedcephalad. Moreover, the shape of the needle may need to be customized oradjusted based on a patient's particular anatomy, thereby furthercomplicating the process.

Furthermore, such catheters are typically very flexible and not verystable within the SVC, and thus easily inadvertently maneuvered out ofan ideal position, particularly during normal dynamic cardiac activity.Even more, the needle is not fixed to the catheter, thereby resulting inaccidental needle exposure, and possibly inadvertent cardiac puncture,which can be lethal. Further complicating this procedure is potentiallydistorted or abnormal anatomy due to, for example, aortic or mitralvalve disease, leading to changes in the location of the FO andobfuscation of typical anatomical landmarks. Yet even more, for patientsundergoing a repeat procedure, the FO may be thickened or scarred,necessitating application of greater puncturing force and increased riskof unintended damage to nearby anatomy.

It can be crucial for many left-heart procedures that the septalpuncture is performed in a specific location within the FO. Fordelivering a replacement mitral valve, for example, it may be importantto puncture an inferior portion of the FO, while for a native valveleaflet clip implant procedure, it may be important to puncture apost/mid portion of the FO. Existing systems do not provide forsufficient accurate and precise targeting of an intended puncture site,such as a particular region within the FO. Failure to puncture theseptum in a proper location can result in prolonged, unsuccessful, orcanceled procedures.

Thus, a need exists for improved devices and methods for faster, morestable, safer, more accurate, and more precise access to the LA.

SUMMARY

Devices and methods are described herein for use in minimally-invasivelyaccessing various portions of a patient's anatomy, such as, for example,accessing a left atrium of a heart through a transseptal puncture. Insome embodiments, a method includes inserting a shaft having (1) a sidecatheter guide attached thereto via a guide coupler, and (2) a guidestabilizer/actuator (“GSA”) in a delivery configuration and slidablyattached thereto, into an inferior vena cava of a heart of a patient anda superior vena cava of the heart such that the GSA is disposed in aright atrium of the heart. The method further includes applying a distalforce to the side catheter guide such that a distal end of the sidecatheter guide deflects laterally about the guide coupler towards aseptum of the heart. The method further includes, with the GSA in itsdelivery configuration in the right atrium of the heart, actuating theguide stabilizer/actuator to transition the GSA from its deliveryconfiguration to a deployed configuration. After initiating the applyingthe distal force and with the guide stabilizer/actuator in its deployedconfiguration, disposing the GSA in contact with the side catheter guideto laterally stabilize the side catheter guide relative to the shaft.The method further includes with the distal end of the side catheterguide laterally deflected about the guide coupler towards the septum andlaterally stabilized by the GSA, extending a side catheter that isdisposed within the side catheter guide distally from the side catheterguide towards and into contact with the septum. The method furtherincludes, with the distal end of the side catheter in contact with theseptum, extending a septum penetrator that is slidably disposed withinthe side catheter distally from the side catheter such that the septumpenetrator pierces the septum.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic illustration of a septum puncture device,disposed in a delivery configuration, according to an embodiment.

FIG. 1B is a schematic illustration of the septum puncture device ofFIG. 1A, disposed in a deployed configuration.

FIG. 2A is a schematic illustration of the septum puncture device ofFIG. 1A, disposed in the delivery configuration within a right atrium(“RA”) of a heart of a patient, and coupled to a first guide wireextending from an inferior vena cava (“IVC”) of the heart across the RAand into a superior vena cava (“SVC”) of the heart.

FIG. 2B is a schematic illustration of the septum puncture device ofFIG. 1A, disposed in the deployed configuration and such that it hasaccessed and delivered to the LA a second guide wire.

FIG. 3 is a flowchart illustrating a method of using a septum puncturedevice to access a left atrium of a heart of a patient, according to anembodiment.

FIGS. 4A and 4B illustrate in perspective and partially exploded view aseptum puncture device 300 in a delivery configuration and a deployedconfiguration, respectively. The septum puncture device 300 is shownpartially exploded to illustrate the lumens defined by the body 310.

FIGS. 5A and 5B illustrate in cross-sectional view a portion of theseptum puncture device 300 of FIGS. 4A and 4B, in perspective view andfront view, respectively.

FIGS. 6A-6H illustrate in side view a deployment sequence of and at adistal end portion of the septum puncture device 300, according to anembodiment.

FIGS. 7A and 7B illustrate a portion of the septum puncture device 300in its delivery configuration and its deployed configuration,respectively.

FIG. 8 illustrates the guide coupler 340 of the septum puncture device300 coupled to and between the main shaft 320 and the side catheterguide 330 in an assembled arrangement (at right), and in detailed,partially assembled, arrangement (at left).

FIG. 9 is a flowchart illustrating a method of using a septum puncturedevice to access a left atrium of a heart of a patient, according to anembodiment.

FIGS. 10-12 illustrate in perspective bottom view, perspective sideview, and side view, respectively, a portion of a septum puncture device500 in a deployed configuration, according to another embodiment.

FIGS. 13A-13F illustrate a partial delivery and deployment sequenceusing the septum puncture device 500 of FIGS. 10-12, according to anembodiment.

FIGS. 14A-14K illustrate an illustrate an example deployment sequence ofa septum puncture device 600, according to an embodiment.

FIGS. 15-17 illustrate a septum puncture device 700 in perspective view,front view, and side view, respectively, according to an embodiment.

FIGS. 18A-18C illustrate a first a guide stabilizer/actuator (“GSA”)850A and a second GSA 850B, of a septum puncture device 800, in adeflated, delivery configuration, a partially inflated, partiallydeployed configuration, and an inflated, deployed configuration,respectively, according to an embodiment.

FIGS. 19-21 illustrate a septum puncture device 900 in perspective view,front view, and detailed, partial perspective view, respectively, thatincludes two side catheters, according to an embodiment.

FIGS. 22 and 23 illustrate a septum puncture device 1000, in front viewand perspective view, respectively, having a single GSA and two sidecatheters, according to an embodiment.

FIGS. 24 and 25 illustrate a septum puncture 1100, in perspective frontview and perspective side view, respectively, having a single GSA and asingle side catheter, according to an embodiment.

FIGS. 26A and 26B illustrate an example delivery and deployment sequenceof the septum puncture device 1100 in the context of a heart of apatient, according to an embodiment.

FIG. 27 illustrates a septum puncture device 1200 having a GSA with aconcave shape and a GSA with a convex shape, according to an embodiment.

FIG. 28 illustrates a septum puncture device 1300 having a GSA with aparticular curvature, according to an embodiment.

FIG. 29 illustrates in top view a septum puncture device 1400 having atri-lobed GSA, according to an embodiment.

FIG. 30 illustrates in top view a septum puncture device 1500 having aGSA with multiple lobes, according to an embodiment.

FIG. 31 illustrates in side view a septum puncture device 1600 havingGSAs configured to limit blood flow occlusion, according to anembodiment.

FIG. 32 illustrates in side view a septum puncture device 1700 havingGSAs rotatably offset and interlocked with each other, according to anembodiment.

FIG. 33 illustrates in side view and top view a septum puncture device1800 having an asymmetric GSA, according to an embodiment.

FIG. 34 illustrates in side view a septum puncture device 1900 definingtwo pathways between GSAs, according to an embodiment.

FIGS. 35A-35D illustrate a deployment sequence of a septum puncturedevice 2000, according to an embodiment.

FIG. 36 illustrates a portion of a septum puncture device 2100 having anintracardiac echo (“ICE”) sensor, according to an embodiment.

FIG. 37 illustrates a portion of a septum puncture device 2200 having acamera, according to an embodiment.

FIGS. 38 and 39 illustrate in cross-sectional side view and front view,respectively, a portion of a septum puncture device 2300, according toan embodiment.

FIGS. 40A and 40B illustrate the stylus 2310, according to anembodiment.

FIG. 41 illustrates handle 2318, according to an embodiment.

FIGS. 42A-42D illustrate an example deployment sequence of the septumpuncture device 2300, according to an embodiment.

FIGS. 43A and 43B illustrate in side view and cross-sectional side view,respectively, a portion of the septum puncture device 2300.

FIG. 44 illustrates in perspective view a portion of the septum puncturedevice 2300 including an end effector.

FIGS. 45A-45D illustrate the end effector of FIG. 44.

FIGS. 46A and 46B illustrate in cross-sectional side view and frontview, respectively, a portion of the septum device 2300, including astiffening element.

FIGS. 47A-48D illustrate a segmented septum puncture device 2400,according to an embodiment.

FIGS. 49-52 illustrate a septum puncture device 2500, according to anembodiment.

FIGS. 53A-53C illustrate various implementations of the septum puncturedevice 2500.

FIGS. 54A-54C illustrate various implementations of the septum puncturedevice 2500.

FIG. 55 illustrates a sheath of the septum puncture device 2500.

FIG. 56 illustrates various implementations of the septum puncturedevice 2500.

FIGS. 57 and 58 illustrate a handle assembly 2680, according to anembodiment.

FIGS. 59A-59D illustrate an example deployment sequence of a septumpuncture device, according to an embodiment.

FIGS. 60A-60D illustrate a portion of a septum puncture device 2700,according to an embodiment.

FIGS. 61A-62B illustrate various implementations of the septum puncturedevice 2700.

FIGS. 63A-63C illustrate a portion of a septum puncture device 2800,according to an embodiment.

FIG. 64 illustrates a portion of a septum puncture device 2900 having aballoon covered in mesh, according to an embodiment.

FIG. 65A is a schematic illustration of a septum puncture device,disposed in a delivery configuration, according to an embodiment.

FIG. 65B is a schematic illustration of the septum puncture device ofFIG. 65A, disposed in a deployed configuration.

FIG. 66A illustrates a portion of a septum puncture device, disposed ina delivery configuration, according to an embodiment.

FIG. 66B illustrates a portion of the septum puncture device of FIG.66A, disposed in a deployed configuration.

FIG. 67 illustrates a portion of a septum puncture device having anatraumatic tip, disposed in a delivery configuration, according to anembodiment.

FIG. 68A illustrates a portion of a septum puncture device having anatraumatic tip, disposed in a delivery configuration, according to anembodiment.

FIG. 68B illustrates a portion of the septum puncture device of FIG.68A, disposed in a deployed configuration.

FIG. 69A illustrates a portion of a septum puncture device having anatraumatic tip, disposed in a delivery configuration, according to anembodiment.

FIG. 69B illustrates a portion of the septum puncture device of FIG.69A, disposed in a deployed configuration.

FIG. 70A illustrates a portion of a septum puncture device in side view,disposed in a deployed configuration, according to an embodiment.

FIG. 70B illustrates the septum puncture device of FIG. 70A in sideperspective view.

FIG. 70C illustrates a portion of the septum puncture device of FIG. 70Ain side view.

FIG. 70D illustrates a portion of the septum puncture device of FIG. 70Ain top perspective view.

FIG. 70E illustrates a portion of the septum puncture device of FIG. 70Ain bottom perspective view.

FIGS. 71A-71D illustrate a portion of a septum penetrator having avariable inner diameter, according to an embodiment.

FIGS. 72A and 72B illustrate a portion of a septum puncture devicehaving an atraumatic tip, disposed in a delivery configuration, in sideview and perspective view, respectively, according to an embodiment.

DETAILED DESCRIPTION

Devices and methods are described herein for use in accessing the leftside of the heart (e.g., LA) from the right side of the heart (e.g., RA)without requiring open-heart surgery. The methods described herein areminimally invasive and utilize a septum puncture device to access theleft side of the heart in a safe (e.g., atraumatic), efficient, timely,accurately and precisely located and repeatable manner. This isaccomplished, in part, by providing a steerable (e.g., translatable androtatable) stable platform between the IVC and SVC from which a puncturemember can be extended laterally and into a target puncture location(e.g., the FO) of the atrial septum.

In some embodiments, a method includes inserting a shaft having (1) aside catheter guide attached thereto via a guide coupler, and (2) aguide stabilizer/actuator (“GSA”) in a delivery configuration andslidably attached thereto, into an inferior vena cava of a heart of apatient and a superior vena cava of the heart such that the guidestabilizer/actuator is disposed in a right atrium of the heart. Themethod further includes applying a distal force to the side catheterguide such that a distal end of the side catheter guide deflectslaterally about the guide coupler towards a septum of the heart. Themethod further includes, with the guide stabilizer/actuator in itsdelivery configuration in the right atrium of the heart, actuating theguide stabilizer/actuator to transition the guide stabilizer/actuatorfrom its delivery configuration to a deployed configuration. Afterinitiating the applying the distal force and with the guidestabilizer/actuator in its deployed configuration, disposing the sidecatheter guide in contact with the side catheter guide to laterallystabilize the side catheter guide relative to the shaft. The methodfurther includes with the distal end of the side catheter guidelaterally deflected about the guide coupler towards the septum andlaterally stabilized by the guide stabilizer/actuator, extending a sidecatheter that is disposed within the side catheter guide distally fromthe side catheter guide towards and into contact with the septum. Themethod further includes, with the distal end of the side catheter incontact with the septum, extending a septum penetrator that is slidablydisposed within the side catheter distally from the side catheter suchthat the septum penetrator pierces the septum.

In some embodiments, a method includes a shaft having a side catheterguide attached thereto via a guide coupler into an inferior vena cava ofa heart of a patient and a superior vena cava of the heart such that theguide coupler is disposed in a right atrium of the heart. The methodfurther includes applying a distal force to a proximal portion of theside catheter guide such that a distal end of the side catheter guidedeflects laterally about the guide coupler towards a septum of theheart. The method further includes, with the distal end of the sidecatheter guide laterally deflected about the guide coupler towards theseptum, extending a side catheter that is disposed within the sidecatheter guide distally from the side catheter guide towards and intocontact with the septum. The method further includes, with the sidecatheter in contact with the septum, extending a septum penetrator thatis slidably disposed within the side catheter distally from the sidecatheter such that the septum penetrator pierces the septum.

In some embodiments, a method includes inserting a shaft having a guidestabilizer/actuator in a delivery configuration and slidably attachedthereto, into an inferior vena cava of a heart of a patient and asuperior vena cava of the heart such that the guide stabilizer/actuatoris disposed in a right atrium of the heart, a side catheter guide beingcoupled to the guide stabilizer/actuator. The method further includes,with the guide stabilizer/actuator in its delivery configuration in theright atrium of the heart, actuating the guide stabilizer/actuator totransition the guide stabilizer/actuator from its delivery configurationto a deployed configuration such that a distal end of the side catheterguide is laterally deflected about the shaft towards the septum of theheart and laterally stabilized in part by the guide stabilizer/actuatorbeing in its deployed configuration. With the guide stabilizer/actuatorin its deployed configuration, the side catheter guide extendsproximally from its distal end that is disposed beyond a first side ofthe shaft, across the shaft, and to a second side of the shaft oppositethe first side of the shaft, and then turns and extends proximallytowards a proximal end of the shaft. The method further includes, withthe distal end of the side catheter guide laterally deflected about theshaft towards the septum and laterally stabilized in part by the guidestabilizer/actuator, extending a side catheter that is disposed withinthe side catheter guide distally from the distal end of the sidecatheter guide towards and into contact with the septum. The methodfurther includes, with the side catheter in contact with the septum,extending a septum penetrator that is slidably disposed within the sidecatheter distally from the side catheter such that the septum penetratorpierces the septum.

In some embodiments, an apparatus includes a body that defines a firstlumen and a second lumen. The apparatus further includes a shaft thathas a first section fixedly coupled to the body and extends distallyfrom the first lumen of the body, and a second section disposedpartially within and telescopable with respect to the first section ofthe shaft. The apparatus further includes a guide wire coupler that iscoupled to the body and extends distally from within a lumen defined bythe shaft. The guide wire coupler defines a guide wire lumen configuredto slidably receive a first guide wire. The apparatus further includes aside catheter guide that is coupled to the body and extends distallyfrom within the second lumen of the body. The side catheter guide iscoupled to the first section of the shaft via a guide coupler. The sidecatheter guide is configured to be transitioned between a deliveryconfiguration and a deployed configuration in which a distal end of theside catheter guide is laterally deflected about the guide coupler whentransitioned from its delivery configuration to its deployedconfiguration. The apparatus further includes a guidestabilizer/actuator that is coupled to the second section of the shaftand configured to transition between a delivery configuration and adeployed configuration to cause the distal end of the side catheterguide to further laterally deflect about the guide coupler and laterallystabilize. The side catheter guide defines a lumen that is configured toslidably receive a side catheter. The side catheter defines a lumenconfigured to slidably receive a puncture member. The puncture member isconfigured to puncture tissue of a patient.

In some embodiments, an apparatus includes a body that defines a firstlumen and a second lumen. The apparatus further includes a shaft thathas a first section fixedly coupled to the body and extends distallyfrom the first lumen of the body, and a second section disposedpartially within and telescopable with respect to the first section ofthe shaft. The apparatus further includes a guide wire coupler that iscoupled to the body and extends distally from within a lumen defined bythe shaft. The guide wire coupler defines a guide wire lumen configuredto slidably receive a first guide wire. The apparatus further includes aside catheter guide that is coupled to the body and extends distallyfrom within the second lumen of the body. The side catheter guide iscoupled to the first section of the shaft via a guide coupler. The sidecatheter guide is configured to be transitioned between a deliveryconfiguration and a deployed configuration in which a distal end of theside catheter guide is laterally deflected about the guide coupler whentransitioned from its delivery configuration to its deployedconfiguration. The side catheter guide defines a lumen that isconfigured to slidably receive a side catheter. The side catheterdefines a lumen configured to slidably receive a puncture member. Thepuncture member is configured to puncture tissue of a patient.

In some embodiments, an apparatus includes a shaft having a proximal endand a distal end, and a lumen extending therethrough. The shaft defines(1) a first aperture, and (2) a second aperture and a third apertureboth disposed distal to the first aperture. The apparatus furtherincludes a first guide stabilizer/actuator (“GSA”) and a second GSA both(1) circumferentially disposed about the shaft, and (2) configured totransition between a delivery configuration and a deployedconfiguration. The apparatus further includes a side catheter guidecoupled to the shaft and extending distally into the lumen at theproximal end of the shaft, exiting the shaft through the first aperture,and extending distally between the first GSA and the second GSA and intothe second aperture, and then exiting the shaft through the thirdaperture. The first GSA and the second GSA are configured such thattransition from the delivery configuration to the deployed configurationcauses a distal end of the side catheter guide to (1) laterally deflectabout, and (2) stabilized relative to, a central axis of the shaft. Theside catheter guide defines a lumen configured to slidably receive aside catheter. The side catheter defines a lumen configured to slidablyreceive a puncture member that is configured to puncture tissue of apatient.

As used herein, the terms “proximal” and “distal” refer to the directioncloser to and away from, respectively, an operator (e.g., a surgeon,physician, nurse, technician, etc.) who would insert the septum puncturedevice into the patient, with the tip-end (i.e., distal end) of thedevice inserted inside a patient's body first. Thus, for example, theend of a main shaft described herein first inserted inside the patient'sbody would be the distal end, while the opposite end of the main shaft(e.g., the end of the main shaft being manipulated by the operator)would be the proximal end of the main shaft.

As used herein, the terms “advance,” “advanced,” and “advancing” eachrefer to distal movement. Advancing a device within a patient'svasculature, for example, refers to moving at least a portion of thedevice distally within the patient's vasculature. Similarly, as usedherein, the terms “withdraw,” “withdrawn,”, and withdrawing” each referto proximal movement. Withdrawing a device within a patient'svasculature, for example, refers to moving at least a portion of thedevice proximally within the patient's vasculature. In some instances,advancing and withdrawing can refer to relative movement of the deviceitself. Advancing a side catheter, for example, can refer to moving aside catheter distally relative to a side catheter guide to which theside catheter is movably coupled. Similarly, withdrawing the sidecatheter, for example, can refer to moving the side catheter proximallyrelative to the side catheter guide to which the side catheter ismovably coupled.

The septum puncture device 100 can be used to access a left side of theheart (e.g., left atrium) from the right side of the heart (e.g., rightatrium) and to deliver a guidewire to the left side of the heart. Asshown in FIG. 1A, the septum puncture device 100 includes a body 110coupled to a main shaft 120, a side catheter guide 130, a side catheter160, and a septum penetrator 170. The main shaft 120 is coupled to theside catheter guide 130 via a guide coupler 140, the side catheter guide130 is coupled to the side catheter 160, and the side catheter 160 iscoupled to the septum penetrator 170, as shown in FIG. 1A. The sidecatheter guide 130 is configured to define a pathway through or acrosswhich the side catheter 160 can travel (e.g., be advanced and/orwithdrawn). Said another way, and as described in further detail herein,the side catheter guide 130 can be manipulated (e.g., actuated from adelivery state to a deployed state) to guide the side catheter 160 in adesired direction (the actuated or deployed state of the side catheterguide 130 is shown in FIG. 1B), e.g., towards the left atrium.

As described in further detail herein, the guide coupler 140 can couplethe side catheter guide 130 to the main shaft 120 to minimize or preventrelative translational movement between the main shaft 120 and the sidecatheter guide 130, but to allow relative rotational movement betweenthe main shaft 120 and the side catheter guide 130, as illustratedschematically in FIG. 1B. In this manner, the guide coupler 140 canfacilitate transition of the side catheter guide 130 from a deliveryconfiguration (e.g., parallel to or substantially parallel to the mainshaft 120), e.g., for insertion through the patient's vasculature andinto the RA, to a deployed configuration such that a distal end of theside catheter guide 130 is deflected laterally (e.g., perpendicular orsubstantially perpendicular) relative to the main shaft 120, e.g.,towards the patient's left atrium (e.g., the FO of the atrial septum).In some embodiments, the guide coupler 140 can be a hinge to facilitatelateral deflection of the side catheter guide 130 relative to the mainshaft 120, as described in further detail herein. In such embodiments,for example, a distal force can be applied to a proximal end portion ofthe side catheter guide 130, thereby causing the hinge to rotate andcause a distal end portion of the side catheter guide (i.e., a portionof the side catheter guide 130 that extends distal to the guide coupler140) to laterally deflect. In some implementations, the amount oflateral deflection or the defined between the side catheter guide 130and the main shaft 120 after such lateral deflection is adjustable bythe operator intra-procedure, i.e., in real-time, such that, forexample, the operator has procedural flexibility when locating thetarget puncture location.

In some implementations, one or more of the main shaft 120, the sidecatheter guide 130, or the side catheter 160 can have a circularcross-sectional shape, while in other implementations, one or more ofthe main shaft 120, the side catheter guide 130, or the side catheter160 can have a non-circular cross-sectional shape. In some instances,for example, the main shaft 120 and the side catheter guide 130 can havecircular cross-sectional shapes, and can be operably coupled together,as discussed in further detail herein, such that the main shaft 120 andthe side catheter guide 130 are at least partially disposed side-by-side(e.g., during delivery). In other instances, for example, the main shaft120 may have a non-circular cross-section (e.g., a half-moon shape,c-shape a convex or concave shape, or any other suitable noncircularcross-sectional shape) such that when coupled to the side catheter guide130, a portion of the side catheter guide 130 can be nestled within aspace defined at least in part by the non-circular curvature of the mainshaft 120. In this manner, the collective cross-sectional area,footprint, diameter, etc. of the main shaft 120 and side catheter guide130 can be reduced. In some instances, a similar relationship can be hadby the main shaft 120 and the side catheter 160 (e.g., in embodiments inwhich a septum puncture device does not have a side catheter guide).

In some embodiments, the septum puncture device 100 includes a sidecatheter guide stabilizer/actuator (“GSA”) 150 (also referred to hereinas “guide stabilizer/actuator”), and a GSA actuator 154 operably coupledto the GSA 150 and configured to actuate the GSA 150. In someimplementations, the GSA 150 can be configured to stabilize (e.g.,laterally, axially (proximally or distally), e.g., with respect to themain shaft 120) the side catheter guide 130 to facilitate the sidecatheter's 160 engagement with the FO and the septum penetrator's 170penetration of the FO. In this manner, the guide coupler 140 canlaterally deflect the side catheter guide 130, and the GSA 150 canstabilize the side catheter guide 130 (and in turn the side catheter160, optional end effector 162, and septum penetrator 170) to optimizesubsequent penetration of the septum and access to the left atrium. Insome implementations, in addition to or instead of stabilizing the sidecatheter guide 130, the GSA 150 can be configured to laterally deflect(e.g., laterally deflect in addition to the lateral deflection caused orfacilitated by the guide coupler 140, as described above) the sidecatheter guide 130 (and in turn the side catheter 160 and septumpenetrator 170, given their coupling to the side catheter guide 130). Inthis manner, in some implementations, the guide coupler 140 and the GSA150 can collectively laterally deflect and stabilize the side catheterguide 130 (and in turn the side catheter 160, optional end effector 162,and septum penetrator 170) to optimize subsequent penetration of theseptum and access to the left atrium.

The GSA 150 can be manipulatable in any manner suitable to provide theabove-described functionality. In some embodiments, for example, the GSA150 can be a balloon, and as such, it can be configured to be inflatableand deflatable. In such embodiments, the GSA 150 can be fluidicallycoupled to a lumen extending from the GSA 150 to the GA actuator 154such that the GA actuator 154 can selectively deliver fluid to the GAactuator 154 to inflate the GSA 150 (i.e., deploy the GSA 150), andselectively withdraw fluid from the GSA 150 to deflate the GSA 150 forremoval of the GSA 150 from the heart (e.g., after left atrium accesshas been achieved).

In embodiments in which the GSA 150 is a balloon, the balloon can haveany shape and size suitable to perform the desired functions describedherein. In some embodiments, for example, the balloon can becone-shaped, while in other embodiments, it can be at least partiallyconcave, convex, circular, oval, or the like. Further, in someembodiments, the balloon can have one or more lobes, e.g., it can bebi-lobed or tri-lobed, to, for example, allow blood flow along theballoon and past the device. Further, the balloon can have additionalfeatures configured to improve stabilization of the side catheter guide130 (e.g., improve coupling between the balloon and the side catheterguide 130). In some embodiments, for example, a balloon can havedimples, protrusions, ridges, adhesives, etc.

The balloon can be formed of any material or combination of materialssuitable to perform its functionality described herein. In someembodiments, for example, the balloon can be formed of one or more ofPolyethylene, Polyethylene terephthalate (“PET”), a polymer, athermoplastic polymer, an elastomer, nylon, polyurethane, anynon-compliant material, etc. The balloon can be configured to beinflated to any suitable pressure, e.g., from about 2 ATM to about 20ATM, as an example. In some instances, higher inflation pressures canresult in greater or improved rigidity of the balloon, thereby providingbetter stabilization of the side catheter guide, side catheter, septumpenetrator, etc.

The GSA 150 can be formed of any material suitable to perform itsfunctions described herein. In some embodiments the GSA 150 can includeor be formed of shape memory material (e.g., Nitinol) and configured tobe transitioned between a delivery/withdrawal configuration in which theGSA 150 is constrained, compressed, or otherwise placed in a relativelysmall arrangement, and a deployed configuration in which the GSA 150 isunconstrained, expanded, or otherwise placed in a larger arrangementsufficient to laterally deflect or stabilize the side catheter guide 130as described in further detailed herein.

Similar to the guide coupler 140, in some embodiments, the GSA 150 caninclude or be formed of radiopaque material to assist the operator inlocating that portion of the septum puncture device 100 before, during,or after deployment. In this manner, the operator can in real timeselectively position the septum penetrator 170 in a position suitable topenetrate the FO upon actuation of the septum penetrator 170. Inembodiments in which the GSA 150 is a balloon, for example, in someinstances the GSA 150 can be inflated with a contrast agent (or acombination of a contrast agent and another fluid, such as saline) toprovide visualization (e.g., under any suitable imaging modality) forthe operator when the GSA 150 is disposed within the patient.

As described in further detail herein, with the side catheter guide 130laterally deflected and stabilized at a suitable angle relative to theFO or the main shaft 120, and with (1) one or more landmark portions ofthe septum puncture device 100 and (2) a desired puncture location(e.g., the FO) on the septum visible to the operator from outside thepatient, the operator can manipulate the main shaft 120 translationallyor rotationally in any suitable manner to align the side catheter guide130 with the FO.

Further as shown in FIG. 1A, the septum puncture device 100 includes aguide wire coupler 122 configured to couple the main shaft 120 to aguide wire (not shown in FIG. 1A) to facilitate delivery of the septumpuncture device 100 into a patient (e.g., through the vasculature of thepatient) and to the patient's heart, and a guide wire coupler 172configured to couple a guide wire (not shown in FIG. 1A) to the septumpenetrator 170, to facilitate delivery of that guide wire to the leftside of the heart (e.g., the left atrium).

Further as shown in FIG. 1A, the septum puncture device 100 optionallyincludes a shaft actuator 124 operably coupled to the main shaft 120 andconfigured to actuate the main shaft 120 to advance or withdraw the mainshaft 120 relative to the body 110. The septum puncture device 100further includes (1) a side catheter actuator 164 operably coupled toand configured to actuate the side catheter 160 to advance or withdrawthe side catheter 160, thereby transitioning the side catheter 160between a delivery configuration and a deployed configuration (the sidecatheter 160 shown in an actuated or deployed configuration in FIG. 1B),and a (2) a septum penetrator actuator (or “penetrator actuator”) 174 toactuate the septum penetrator 170 to advance or withdraw the septumpenetrator 170, thereby transitioning the septum penetrator 170 betweena delivery configuration and a deployed configuration (the septumpenetrator 170 shown in an actuated or deployed configuration in FIG.1B), as described in further detail herein.

Further as shown in FIG. 1A, the septum puncture device 100 optionallyincludes a GSA (“GA”) 150 coupled to the main shaft 120. The optionalGSA 150 is operably coupled to a GA actuator 154 that is configured toactuate the GSA 150, as described in further detail herein.

Further as shown in FIG. 1A, the septum puncture device 100 optionallyincludes an end effector 162 coupled to and extending distally from theside catheter 160. The end effector 162 is configured to facilitatesubsequent puncture through a target puncture location, such as, forexample, the FO of the septum of the heart. The end effector 162 can beconfigured, for example, to contact or tent the FO, as described infurther detail herein. Such contact or tenting of the FO can, forexample, reduce or minimize the force required to penetrate the FOand/or provide for improved force distribution to the FO. The endeffector 162 can be configured to prevent inadvertent puncturing ofand/or damage to the FO with the end effector 162.

In some embodiments, the end effector 162 is formed of or includes aradiopaque material such that the end effector 162 can be visualizedwhen within the heart from outside the patient under any suitableimaging modality (e.g., fluoroscopy, echocardiography, etc.), tofacilitate an operator in deploying the end effector 162, e.g., locatingthe end effector 162 within the heart or relative to the FO inpreparation for deploying the septum penetrator 170.

In some embodiments, the end effector 162 can include multipleconfigurations, e.g., a delivery or withdrawal configuration, in whichthe end effector 162 is configured to be routed through the patient'svasculature, and a deployed configuration in which the end effector 162is configured to facilitate subsequent penetration of the FO, asdescribed in further detail herein. In such embodiments, for example,the end effector 162 can be delivered to the heart in a compressed,deflated, or otherwise relatively small configuration, and thentransitioned into a deployed configuration in which it is expanded,inflated, or otherwise increased in size to then contact or tent the FO.Further, in some embodiments, after deployment of the end effector 162,the end effector 162 can be transitioned to a withdrawal configuration(which can be the same as or similar to its delivery configuration) inwhich the end effector 162 is in a compressed, deflated, or otherwisesmall configuration to assist in removal of the end effector 162 fromthe patient.

The end effector 162 can be formed of any suitable material(s) tofacilitate its functionality described herein. In some embodiments, forexample, the end effector 162 can be formed of shape memory material(s)(e.g., Nitinol) or a polymer, or a combination thereof (e.g., Nitinolcoated with a polymer), such that it can be transitioned between aconstrained or compressed arrangement (e.g., delivery or withdrawalconfiguration) and an unconstrained or expanded arrangement (deployedconfiguration). In some embodiments, for example, the end effector 152can be or include a balloon such that it can be delivered to the heartin a deflated arrangement and then inflated (e.g., via an inflationlumen fluidically coupled to and extending proximally from the endeffector 162, not shown) to a deployed configuration. Various furtherembodiments of an end effector are described in further detail below.

Each of the main shaft 120, the guide wire coupler 122, the sidecatheter guide 130, the guide coupler 140, the optional GSA 150, theside catheter 160, the septum penetrator 170, and the guide wire coupler172 are translatable (e.g., distally advanceable and/or extendable, andproximally withdrawable and/or retractable) relative to the body 110.The side catheter 160 is translatable relative to the side catheterguide 130, and the septum penetrator 170 is translatable relative to theside catheter 160, as described in further detail herein.

The septum penetrator 170 can be sized, shaped, and formed of anymaterial suitable to effectively penetrate and traverse a target tissuesuch as the FO. In some embodiments, for example, the septum penetrator170 can be a needle. In some embodiments, the septum penetrator 170 canbe a non-coring needle (e.g., a needle with a sharp tip that has acutting edge, such as, for example, a Quincke-type needle). In someembodiments, the septum penetrator 170 can have variable materialproperties. In such embodiments, for example, a distal portion of theseptum penetrator 170 can have a stiffness greater than a stiffness of aportion proximal to that distal portion. In this manner, the stifferdistal portion can be configured for penetration through the septum,while the portion proximal can be configured for delivery through thepatient's vasculature. In some embodiments, the septum penetrator 170can be solid-tipped and can be electrified with radiofrequency (“RF”)energy to puncture the FO.

The septum penetrator 170 can have any suitable length, for example, anylength suitable to reach the LA. In some embodiments, for example, theseptum penetrator 170 can have an effective length (i.e., the lengthextendable from the distal end of the side catheter 160 (or from thedistal end of the end effector 162) of about 5 mm to about 25 mm. Insome instances, an effective length of the septum penetrator 170 can beabout 8 mm or about 10 mm, or any length therebetween. In someembodiments, the septum penetrator 170 can contain or be configured toreceive a stylet to limit or minimize tissue coring. In someembodiments, the septum penetrator 170 can include a pressure transducer(not shown) configured to monitor pressure through a lumen of the septumpenetrator 170. In some embodiments, a port or leuer lock can beincorporated into the septum puncture device 100 to flush the septumpenetrator 170.

Turning to FIGS. 2A and 2B to describe the septum puncture device 100(1) in context with the anatomy of a patient and (2) in a sampleprocedure to access the LA of the patient, FIG. 2A is a schematicillustration of the septum puncture device 100 disposed in a deliveryconfiguration within the RA of the heart and coupled to a first guidewire GW1 extending from the IVC across the RA and into a SVC and FIG. 2Bis a schematic illustration of the septum puncture device 100 disposedin a deployed configuration and such that it has accessed and deliveredto the LA a second guide wire that can be used to provide subsequentaccess to the LA.

In use, prior to introducing into the patient the septum puncture device100, a guide wire GW1 can be inserted through an entry site of thepatient (e.g., femoral vein puncture site) (not shown) and advancedthrough the patient's vasculature across the IVC and RA, and into theSVC using known, suitable techniques for guidewire delivery. With theguide wire GW1 disposed in such a manner, the septum puncture device 100can be movably coupled to the guide wire GW1 via the guide wire coupler122 and advanced from the entry site of the patient towards the heart.In some embodiments, the guide wire coupler 122 can be a lumen definedby the main shaft 120 through which the guide wire GW1 can be disposedand such that the main shaft 120 can be slidably disposed about theguide wire GW1. The guide wire GW1 can be any suitable size. In someembodiments, for example, the guide wire GW1 can have a diameter ofabout 0.014 inches to about 0.035 inches in diameter. In someembodiments, the guide wire GW1 can be about 0.025 inches diameter. Withthe guide wire coupler 122 movably coupled to the delivered guide wireGW1, the septum puncture device 100 can be advanced along the guide wireGW1 into the heart, as shown in FIG. 2A. More specifically, with themain shaft 120 coupled to (1) the body 110 and (2) the side catheterguide 130 via the guide coupler 140, the body 110, the main shaft 120,the guide coupler 140, the side catheter guide 130, the side catheter160, the septum penetrator 170, and the guide wire coupler 172 all canbe advanced into the heart of the patient as shown in FIG. 2A, such thatbody 110 extends through the IVC and into the RA, and the main shaft 120extends into the SVC. With the main shaft 120 spanning the IVC, RA, andSVC, the main shaft 120 can provide a foundation or backstop againstwhich the side catheter guide 130, side catheter 160, and septumpenetrator 170 can be deployed and advanced towards the septum, asdescribed in further detail herein.

In some instances, a distal end of the (1) main shaft 120, (2) sidecatheter guide 130, (3) side catheter 160, and septum penetrator 170(and accompanying couplers, e.g., the guide wire coupler 122 and theguide wire coupler 172), can be disposed within the body 110 (e.g.,within one or more lumens (not shown) defined by the body 110). In thismanner, during delivery, the patient's anatomy can be protected orshielded by the body 110 to avoid inadvertent trauma to or contact withthe patient's anatomy from such components. With a distal end of thebody 110 disposed in or near the RA, the body 110 can be withdrawn(and/or one or more of the components movably coupled thereto can beadvanced), thereby exposing the side catheter guide 130 and guidecoupler 140 within the RA.

With the side catheter guide 130 exposed within the RA andtranslationally fixedly coupled to the main shaft 120 via the guidecoupler 140, the side catheter guide 130 can be actuated to laterallydeflect the distal end of the side catheter guide 130 (and as a result,also the side catheter 160, the septum penetrator 170, and the guidewire GW2 if disposed in the side catheter guide 130 during its lateraldeflection), as shown in FIG. 2B. The side catheter guide 130 can belaterally deflected at any angle suitable to direct the side catheter160 and septum penetrator 170, which are movably attached to the sidecatheter guide 130, towards the target penetration site, e.g., the FO,as shown in FIG. 2B. In some instances, an optimal angle of entry to theFO is 90 degrees or substantially 90 degrees relative to a surface linetangent to the FO, which can be about a similar angle relative to acentral axis of the main shaft 120. Such a perpendicular (orsubstantially perpendicular) angle of entry can minimize the forcerequired to penetrate the FO because the entire or substantially entireforce vector is directed at the plane of the FO (rather than atangential approach). Additionally, such a perpendicular (orsubstantially perpendicular) angle of entry, given the nature of apatient's anatomy, directs the septum penetrator 170 to a relativelylarge open space within the LA, thereby minimizing risk of inadvertentpuncture within the LA (e.g., inadvertent puncture of a wall of the LA).

In other instances, the angle of entry relative to the FO or relative tothe central axis of the main shaft 120 can be anywhere within a range ofabout 50 degrees to about 90 degrees. In some instances, the preferredangle of entry can be selected based on a particular therapy planned forthe left side of the heart. The angle of entry, for example, defines thetrajectory for the subsequent therapeutic device to enter the left sideof the heart, and so in some instances an optimal angle and location ofentry through the FO is based on a particular therapeutic device orprocedure.

Note that the guide wire GW2 can be delivered in any suitable manner. Insome instances, for example, the guide wire GW2 is disposed within theside catheter guide 130 during delivery of the side catheter guide 130,while in other instances the guide wire GW2 is inserted at a later timeduring the procedure, e.g., after the septum penetrator 170 haspenetrated the FO and reached the LA.

With the side catheter guide 130 transitioned to its deployedconfiguration, in which the side catheter guide 130 is laterallydeflected towards the FO, the side catheter actuator 164 can be actuatedto advance the side catheter 160 along a path defined at least in partby the side catheter guide 130 and towards the FO. In some instances theside catheter 160 is advanced until it's distal end tents or otherwisecontacts the FO. For embodiments that include the end effector 162, theside catheter 160 can be advanced until the end effector 162 extendingfrom the distal end of the side catheter 160 tents or otherwise contactsthe FO.

In embodiments in which the end effector 162 is expandable andcompressible, the end effector 162 can be delivered to the Right AtriumRA in a compressed or relatively small configuration, and thentransitioned to a deployed configuration in which the end effector 162is expanded to a relatively larger configuration, and then advanced toengage with the FO. After sufficient penetration of the Atrial Septum ASwith the septum penetrator 170, as described in further detail herein,the end effector 162 can be transitioned to its retracted or compressedconfiguration suitable to be withdrawn from the patient. In embodimentsin which the side catheter 160 is slidably disposed within a lumendefined by the side catheter guide 130, the end effector 162 cansimilarly be slidably disposed within the lumen defined by the sidecatheter guide 130 such that the side catheter guide 130 contains theend effector 162 in its constrained or compressed configuration duringdelivery, and then as the side catheter actuator 164 is actuated toadvance the side catheter 160 distally from the distal end of the sidecatheter guide 130, the end effector 162 can transition to its expandedor unconstrained configuration as or after it exits the lumen of theside catheter guide 130.

With the side catheter 160 (or end effector 162) in sufficient contactwith the FO, the penetrator actuator 174 can be actuated to advance theseptum penetrator 170 relative to and along a path defined at least inpart by the side catheter 160. The septum penetrator 170 can be advancedthrough the FO and across the Atrial Septum AS and into the Left AtriumLA. In some embodiments, the side catheter 160 defines a lumen throughwhich the septum penetrator 170 is slidably disposed such that actuatingthe penetrator actuator 174 advances the septum penetrator 170 throughthe lumen of the side catheter 160. The septum penetrator 170 can beadvanced in this manner to penetrate the FO and to extend into the leftatrium LA. During such penetration, the main shaft 120 can providelateral or axial stability to the septum penetrator 170.

As the distal end of the septum penetrator 170 is advanced across theAtrial Septum AS and into the Left Atrium LA, the guide wire GW2 canfollow via the guide wire coupler 172 and the septum penetrator 170 ininstances in which the guide wire GW2 is coupled to the side catheterguide 130 during delivery of the side catheter guide 130. In otherinstances, the guide wire GW2 can be inserted at a later time during theprocedure, e.g., after the septum penetrator 170 has penetrated the FOand reached the LA In some embodiments, the guide wire coupler 172 is alumen defined by the septum penetrator 170 and through which the guidewire GW2 can be slidable disposed. In such embodiments, the guide wireGW2 can be disposed within the lumen of the septum penetrator 170 duringdelivery and deployment of the septum penetrator 170 into the LeftAtrium LA.

With the septum penetrator 170 and the guide wire GW2 disposed withinthe Left Atrium LA, the guide wire GW2 can be further advanced into theLeft Atrium LA by manipulation of the guide wire GW2 at its proximalend, and/or the septum penetrator 170 can be withdrawn from the LeftAtrium LA, across the puncture or entry site of the FO, leaving theguide wire GW2 within the Left Atrium LA.

With the guide wire GW2 delivered to the Left Atrium LA, and extendingproximally from the Left Atrium LA across the puncture or entry site ofthe FO, into the Right Atrium RA, the IVC, and through the vasculatureof the patient to the entry point of the patient (for subsequent accessto the Left Atrium AS), the septum puncture device 100 can be withdrawnfrom the heart proximally over guide wire GW2 and from the patient.

The guide wire GW2 can be any guide wire suitable to provide desirablesubsequent access to the Left Atrium LA. In some embodiments, forexample, the guide wire GW2 can be a pigtail, atraumatic guide wire orother suitable guide wire conventionally used in transseptal procedures.For example, the guide wire GW2 can have a flexible, spiral tip,pigtail, and can be configured to anchor the septum puncture device 100to the LA, thereby limiting or preventing the guide wire GW2 from beinginadvertently withdrawn or removed from the LA in response to or whilethe septum puncture device 100 is being withdrawn along the guide wireGW2 and from the patient. Another example guide GW2 can be a ProTrack™Pigtail Wire from Baylis Medical Company, Inc.

The septum puncture device 100 can be configured to be withdrawn fromthe patient in any suitable sequence (e.g., after the guide wire GW2 hasbeen delivered to the Left Atrium LA). With the guide wire GW2 disposedwithin the Left Atrium LA, for example, the portions of the septumpenetrator 170 and guide wire coupler 172 disposed within the LeftAtrium LA can be withdrawn relative to the guide wire GW2 and throughthe puncture site in the FO and into the Right Atrium RA. In embodimentsin which the side catheter 160 defines a lumen through which the septumpenetrator is slidably disposed, the septum penetrator 170 can bewithdrawn relative to and into the lumen defined by the side catheter160. In this manner, the septum penetrator 170, and particular it'sdistal that is designed to penetrate tissue, can be sheathed or shieldedby the side catheter 160 to facilitate safe withdrawal from the patientand avoid inadvertent contact with the patient's heart or vasculatureduring removal of the septum puncture device 100 from the patient.

Similarly, the side catheter 160 can be withdrawn relative to the sidecatheter guide 130. For example, in embodiments in which the sidecatheter guide 130 defines a lumen through which the side catheter 160is slidably disposed, the side catheter 160 can be withdrawn into thelumen of the side catheter guide 130. In embodiments in which the septumpuncture device 100 includes an end effector 162, the side catheterguide 160 can be withdrawn relative to and into the lumen of the sidecatheter guide 130 such that the end effector 162 is also withdrawn intothe lumen of the side catheter guide 130. In embodiments in which theend effector 162 has a deployed configuration with a diameter largerthan an internal diameter of the side catheter guide 130, the endeffector 162 can be configured to be transitioned from its deployedconfiguration to its withdrawal (or delivery) configuration. Forexample, if the end effector 162 is a balloon, it can be deflated andthen withdrawn into the lumen of the side catheter guide 130. As anotherexample, if the end effector 162 includes or is formed of shape memorymaterial, the end effector 162 can be compressed, constrained, orotherwise transitioned to a smaller arrangement such that it can bewithdrawn into the side catheter guide 130. In some instances,withdrawal of the end effector 162 into the side catheter guide 130 cancause the end effector 162 to transition to its constrained orcompressed configuration.

Further, the side catheter guide 130 can be configured to transitionfrom its deployed configuration in which its distal portion is laterallydeflected relative to the main shaft 120 to its withdrawal (or delivery)configuration in which the side catheter guide 130 is at leastsubstantially linear and parallel to the main shaft 120. In someembodiments, for example, a proximal force can be applied to a proximalend portion of the side catheter guide 130 to withdraw the side catheterguide 130 relative to the main shaft.

With the septum puncture device 100 disposed as shown in FIG. 2A, forexample, after delivering the guide wire GW2, the septum puncture device100 can be withdrawn from the heart and from the patient. For example,the body 110, and all of the components coupled thereto, can bewithdrawn from the heart, through the patient's vasculature, and outthrough the initial entry site into the patient (e.g., a femoralpuncture site).

Although embodiments described herein refer to introducing a guide wireand septum puncture device into the patient's vasculature, and acrossthe IVC and RA, and into the SVC, access to the RA for purposes ofdeploying a septum penetrator, can be accomplish in a variety of ways.In some embodiments, for example, the guide wire and septum puncturedevice can be inserted into a patient's jugular vein (e.g., rightinternal jugular vein), and then advanced into and across the SVC andRA, and into the IVC, such that a distal end of the septum puncturedevice is disposed in the IVC (or beyond).

Although embodiments described herein refer to a single FO puncture todeliver a single guide wire to the LA, it should be understood that theseptum puncture devices described herein can be used to perform multiplepunctures and to deliver multiple guide wires. In some instances, forexample, a double puncture and delivery of two guide wires may bedesirable, e.g., in connection with an atrial fibrillation ablationprocedure. In such instances, the septum puncture devices describedherein can be deployed twice to puncture the septum twice, with eachpuncture providing access to deliver a guide wire, as described herein.In some procedures that require multiple punctures and guide wiresdelivered to the LA, for example, it can be crucial that the puncturesare in a particular location and located a particular distance from eachother, and as described through this disclosure, the septum puncturedevices described herein provide just that.

Further, instead of using a septum puncture device described herein toadminister multiple punctures in series (e.g., with a single penetrator,single side catheter, single side catheter guide, etc.), in someembodiments, any of the septum puncture devices described herein can bemodified to incorporate additional components. For example, in someinstances, a septum puncture device can include a body and a main shaft(similar to septum puncture device 100), but also include two sidecatheter guides, two side catheters, two end effectors, two septumpenetrators, and two guide couplers (for the guide wires beingdelivered), and optionally one or two guide couplers and one or twoguide stabilizer/actuators. In this manner, two side catheter guides canbe deployed (i.e., laterally deflected and stabilized) simultaneously,and then two side catheters (optionally with end effectors) can beadvanced, optionally simultaneously, to contact the septum, and then twoseptum penetrators can be advanced, optionally simultaneously, topenetrate the septum. With two punctures in the septum, two guide wirescan then be delivered, optionally simultaneously. In such instances, thepreferred distance between the two punctures can be selectively definedby the distance between the side catheters from which the septumpenetrators are advanced.

FIG. 3 illustrates a method 200 of using the septal puncture device 100to access a left atrium of a heart of a patient, according to anembodiment. At 201, the guide wire GW1 is inserted through the IVC,across the RA, and into SVC of the heart (e.g., via a femoral veinpuncture and through the patient's vasculature disposed between thefemoral vein puncture site and the IVC). At 202, the septal puncturedevice 100 is delivered over the guide wire GW1 until a distal end of amain shaft 110 is disposed within the SVC. At 204, the GSA 150 isactuated to laterally deflect and direct the side catheter guide 130towards the FO. Optionally, at 206, the main shaft 110 and the sidecatheter guide 130 are selectively positioned (e.g., translated orrotated) relative to the FO. Optionally, at 208, the end effector 162 isdeployed. At 210, the end effector 162 (or distal end of side catheter)is advanced against and into contact with the FO (e.g., to tent the FO).Optionally, at 212, the end effector 162 (or distal end of side catheter130) is visualized from outside the patient, and if necessary, the mainshaft 110 or the side catheter guide 130 are adjusted to selectivelyreposition the end effector 162 (or distal end of side catheter 130)relative to the FO.

At 214, the septum penetrator 170 is advanced through the FO and intothe LA. Optionally, at 216, visualization techniques are used to confirmcrossing of the septum penetrator 170 into the LA. At 220, the guidewire GW2 is advanced relative to the septum penetrator 170 and into theLA or the septum penetrator 170 is withdrawn relative to the septumpenetrator 170, thereby leaving a portion of the guide wire GW2 in theLA. At 222, the septum penetrator 170 is withdrawn, the end effector 162is optionally withdrawn, the main shaft 120 is withdrawn, the guideactuator 150 is deactuated, and the device 100 is withdrawn over theguide wire GW1 and removed from the patient.

Although not shown, in some embodiments, any of the main shaftsdescribed herein can define a channel through which an intra-cardiacecho can be disposed or slidably coupled to assist in navigation throughthe patient.

FIGS. 4A and 4B illustrate in perspective view a septum puncture device300 in a delivery configuration and a deployed configuration,respectively; FIGS. 5A and 5B illustrate a cross-sectional view of aportion of the septum puncture device 300, in perspective view and frontview, respectively; and FIGS. 6A-6H illustrate a deployment sequence ata distal end portion of the septum puncture device 300, according toanother embodiment.

Similar to or the same as described with respect to the septum puncturedevice 100, the septum puncture device 300 can be used to access a leftside of the heart (e.g., left atrium) from the right side of the heart(e.g., right atrium) and to deliver a guidewire to the left side of theheart. The septum puncture device 300 can be constructed the same as orsimilar to, and can function the same as or similar to, the septumpuncture device 100. Thus, portions of the septum puncture device 300are not described in further detail herein.

In this embodiment, the septum puncture device 300 includes a body 310defining a first lumen 311 and a second lumen 312, through which variousportions of the septum puncture device 300 are disposed or slidablydisposed, as described in further detail herein. Coupled to the body 310are a main shaft 320 and a side catheter guide 330, and the main shaft320 is coupled to the side catheter guide 330 via a guide coupler 340.As shown in FIGS. 5A and 5B, a proximal end portion of the side catheterguide 330 is disposed within the second lumen 312 of the body 310. Theside catheter guide 330 defines a lumen through which a side catheter360 is slidable disposed, the side catheter 360 defines a lumen throughwhich a septum penetrator 370 is slidably disposed, and the septumpenetrator 370 defines a lumen through which a guide wire GW2 can beslidably disposed (as shown in FIGS. 5A, 5B, and 6H). Extendable from adistal end portion of the side catheter 360 is an end effector 362.

The main shaft 320 is telescopable, i.e., capable of beingexpanded/extended/advanced and contracted/withdrawn in sections. Themain shaft 320 includes a proximal section 320A, and an inflationsection 320B disposed partially within and telescopable distally withrespect to the proximal section 320A. Although not shown, in someembodiments, the septum puncture device 300 can include a lock operablycoupled to the inflation section 320B of the main shaft 320 andconfigured to translationally fix the inflation section 320B with theproximal section 320A to at least temporarily limit or prevent relativemovement therebetween. In this manner, an operator can selectivelyenable and disable the telescopable feature of the main shaft 320, asdescribed in further detail herein.

The proximal section 320A of the main shaft 320 is coupled to anddisposed within the first lumen 311 of the body 310, and extendsdistally from a distal end of the body 310. In some implementations ofthis embodiment, the proximal section 320A of the main shaft 320 isfixedly coupled to the body 310 (e.g., welded within the first lumen 311of the body). Disposed circumferentially about and fluidically coupledto the inflation section 320B of the main shaft 320 (the inflationsection 320B being fluidically and slidably coupled to the proximalsection 320A) is a guide stabilizer/actuator (“GSA”) 350. In thisembodiment, the GSA 350 is a balloon configured to be inflated fordeployment and deflated for delivery or withdrawal. To inflate, the GSA350 is configured to receive one or more fluids (e.g., one or more ofsaline, air, or a contrast agent for visualization) via the inflationsection 320B. In use, for example, one or more fluids can be conveyedfrom a lumen defined by the proximal section 320A to a lumen defined bythe inflation section 320B and into a volume defined by the GSA 350. Thesame fluid(s) can be withdrawn from the GSA 350 (e.g., via the samepathway used to deliver the fluid(s)) to deflate the GSA 350 such thatthe GSA 350 can be withdrawn from the patient. The balloon can be anysize suitable to perform that desired functionality disclosed herein,for example, in some embodiments, the balloon can be about 10 mm toabout 60 mm in diameter when inflated. In some embodiments, for example,the balloon can be 20 mm or about 20 mm in diameter when inflated. Insome implementations of this embodiment, the septum puncture device 300can include a GA actuator (not shown, but e.g., disposed at or operablycoupled to the handle 380) configured to inflate or deflate the GSA 350.

As shown, the inflation section 320B includes an inflation portion 326,circumferentially about which the GSA 350 is disposed, and a distalportion 327 extending distally from the GSA 350. In use, for example,with the GSA 350 deployed within the right atrium of the heart of thepatient, the distal portion 327 extends into the SVC of the patient toprovide stability between the IVC and SVC for subsequent puncture of theFO. Although not shown, in some embodiments, the distal portion 327 canhave a diameter greater than a diameter of the inflation portion 326. Inthis manner, the cross-sectional area or footprint collectively assumedwithin the atrium of the heart by the GSA 350 and the inflation portion326 about which the GSA 350 is coupled can be minimized while thediameter of the distal portion 327 can be relatively larger to provideadditional stability (e.g., by having relatively greater stiffness) toensure a stable platform bridged between the IVC and SVC. In otherembodiments, for a similar purpose, other design considerations (e.g.,thickness, material, etc.) can be employed to increase the stiffness orstability of the distal portion 327, relative to the inflation portion326.

Disposed within the first lumens defined by the main shaft 320 is aguide wire coupler 322. The guide wire coupler 322 extends distally fromthe body 310 and is configured in use to extend from the body 310 to theSVC of the patient. The guide wire coupler 322 defines a lumen throughwhich the guide wire GW1 can be routed and slidably disposed. In someimplementations of this embodiment, the guide wire coupler 322 isfixedly coupled (e.g., welded) to an inner surface of the main shaft320. As shown best in FIG. 5B, an inflation volume IV (e.g., acrescent-shaped void or volume) is defined between an external surface aportion of the guide wire coupler 322 and an inner surface of the mainshaft 320. This volume is fluidically coupled to the GSA 350 disposedabout the main shaft 320 such that it provides a conduit through whichfluid can be delivered from outside the patient to the interior of theGSA 350 when the GSA 350 is disposed within the heart of the patient.

In this embodiment, the guide coupler 340 is formed from a single threadof suture (although in other embodiments a guide coupler 340 could beformed from any suitable number of sutures, e.g., two or more). Anysuture suitable to translationally fixedly couple the main shaft 320with the side catheter guide 330, but allow relative rotationallymovement between the main shaft 320 and the side catheter guide 330, canbe used. In some embodiments, for example, a polymer such as Dacron, canbe used.

To couple the guide coupler 340 with the main shaft 320 and sidecatheter guide 330, the suture can be circumferentially wrapped aroundeach of the side catheter guide 330 and main shaft 320 separately andcan be circumferentially wrapped around the side catheter guide 330 andmain shaft 320 collectively. For additional securement, in someembodiments, an adhesive can be applied between the guide coupler 340and the main shaft 320, between the guide coupler 340 and the sidecatheter guide 330, or between the side catheter guide 330 and the mainshaft 320, or any combination thereof.

As with many minimally-invasive surgical procedures in the cardiacspace, it can be important to minimize the size, and in particular thecross-sectional footprint, of the device(s) inserted into the patient.Forming the guide coupler 340 with suture addresses this goal byallowing for flush or substantially flush contact (e.g., direct orsubstantially direct contact) between the main shaft 320 and the sidecatheter guide 330. In some embodiments, for example, the suture can bewrapped around each of the main shaft 320 and the side catheter guide330 such that the distance between an external surface of the main shaft320 and an external surface of the side catheter guide 330 is equal toor substantially equal to an external diameter of the thread of suture.In such embodiments, using, for example, a suture having a United StatesPharmacopeia (“USP”) of 4-0 having an external diameter of 0.15 mm canallow for a distance between the main shaft 320 and the side catheterguide 330 of 0.15 mm. In some implementations, other suture sizes couldbe used, such as, for example, USP 2-0, USP 3-0, USP 5-0, USP 6-0, orUSP 7-0.

Although in this embodiment the guide coupler 340 is formed of suture,in other embodiments, a guide coupler can be formed, additionally oralternatively, of other materials, such as, for example, a textile,polymer, fine wire, metal, or braided material. As another example, insome embodiments a guide coupler can be a sleeve (e.g., a textilesleeve), and in some implementations, the sleeve could serve inconjunction with a suture (e.g., formed into a cow hitch), and the freeends of the suture can be stabilized with an adhesive coating.

Further, in this embodiment, and as shown FIG. 4B, the side catheterguide 330, from top view, is disposed to the right of the main shaft320. Offsetting the side catheter guide 330 relative to the central axisof the main shaft 320 in this manner in many instances aligns the distalend of the side catheter guide 330 with the FO, given the commonanatomical location of the FO relative to the IVC, SVC, and RA. The FOis often offset from a central axis defined from the IVC to the SVC, soaligning the side catheter guide 330 to be offset from the central axisof the main shaft 320, may in some instances, place the side catheterguide 330 in a more suitable position for subsequent puncture. In thismanner, the arrangement of the side catheter guide 330 and the mainshaft 320 can optimize the time and number of steps required of theoperator to locate the FO with the side catheter 360 (or end effector362), for subsequent puncturing of the FO with the septum penetrator370.

Similar to as described elsewhere herein, in this embodiment, the septumpuncture penetrator 370 has variable stiffness. More specifically, adistal end portion of the septum penetrator 370 is configured to bestiffer/more rigid than a proximal end portion of the septum penetrator370, with the distal end portion being optimized to penetrate the FO andthe proximal end portion being optimized to advance (with flexibility)through the curved side catheter guide 330. Accommodating a rigid septumpenetrator 370 suitable to puncture the septum and be able to make asuitable turn from the central axis of the main shaft 320 within the RAand towards the FO, can be challenging given the anatomical spatialconstraints within the heart.

To address such constraints, as shown in FIG. 4B, the side catheterguide 330, when deployed, assumes a curved shape as it extends distallyfrom the body 310. More specifically, in front view, the side catheterguide 330 extends proximally from its distal end and from below thecentral axis of the main shaft 320, across the central axis of the mainshaft 320 and above the central axis of the main shaft 320, and thencurves left and towards and into the second lumen 312 of the body 310.In this manner, a linear section at the distal end portion of the sidecatheter guide 330, when deployed, can have a length sufficient toslidably contain or house the septum penetrator 370. That length, forexample, can be greater than a thickness of the FO. In some embodiments,that length can be about 5 mm to about 15 mm, or greater. In thisembodiment, that length is greater than a diameter of the GSA 350 whendeployed. Further, this curved configuration allows for a more graduallateral deflection/turn towards the FO than would otherwise beattainable, e.g., rather than the lateral deflection towards the FObeing initiated from a linear axis parallel to the central axis of themain shaft 320.

In use, for example, when advancing the main shaft 320 from entry intothe patient, through the patient's vasculature, and into the IVC, RA,and SVC, it is desirable to avoid any traumatic contact with thepatient's anatomy. To limit or prevent undesirable trauma to the patientfrom the septum puncture device 300, in this embodiment the septumpuncture device 300 includes a flexible, atraumatic distal component 328coupled to and extending from the main shaft 320. Although thisembodiment illustrates the atraumatic distal component 328 as a separatecomponent that is coupled to the main shaft 320, in other embodiments adistal end portion (e.g., a distal tip) of the main shaft 320 can beconfigured to be atraumatic (e.g., flexible, soft, or any other designfeatures configured to avoid undesirable trauma to the patient). Theatraumatic distal component 328, in some implementations, can be taperedsuch that its proximal end portion has a cross-sectional area greaterthan its distal end portion. In some instances, the portion of theatraumatic distal component 328 having the greatest cross-sectionalarea, diameter, or width, can have the same, about the same, or largercross-sectional area, diameter, or width of the GSA 350 (when the GSA350 is in its delivery configuration). In this manner, the atraumaticdistal component 328 can facilitate a smooth delivery through thepatient.

Further, as shown, the septum puncture device 300 includes a handle 380coupled to the body 310 and configured to be manipulatable by theoperator to deliver and deploy the septum puncture device 300 asdescribed in more detail herein. The handle 380 can include or becoupled to one or more shaft actuators (when included, not shown), theGA actuator 354, a side catheter actuator (not shown), and a penetratoractuator (not shown). Further, the handle can be manipulatable toactuate one or more of the actuators.

Turning now to an exemplary deployment sequence, FIGS. 6A-6H illustratein side view an exemplary deployment sequence of and at a distal endportion of the septum puncture device 300, according to an embodiment.

FIG. 6A illustrates a portion of the septum puncture device 300 prior todeployment. It is in this configuration that the septum puncture device300 can be inserted into the patient (e.g., via a femoral veinpuncture), through the patient's vasculature, and into the heart of thepatient such that the main shaft 320 extending distally from the body310 spans the IVC, RA, and SVC to provide a stable platform againstwhich the septum puncture device 300 can be deployed to puncture the FO.As shown, during delivery the septum puncture device 300 is in itsdelivery configuration in which the main shaft 320 and the side catheterguide 330 are parallel or substantially parallel to each other. In thismanner, for example, the cross-sectional footprint of the septumpuncture device 300 can be minimized or optimized for minimally-invasivedelivery through the patient.

As shown in FIG. 6A, during delivery the distal end of the side catheterguide 330 is in physical contact with a proximal side of the GSA 350. Insome instances, for example, the proximal side of the GSA 350 and thedistal end of the side catheter guide 330 can be in such close contactthat a portion of the distal end of the side catheter guide 330 can benestled partially within, or covered partially by the proximal side ofthe GSA 350. In this manner, the GSA 350 can shield the distal end ofthe side catheter guide 330 from inadvertent contact with the patient'sanatomy. In such instances, a subsequent step can include telescopingthe main shaft 320, including advancing the inflation section 320B ofthe main shaft 320 to separate the distal end of the side catheter guide330 from the GSA 350 or unshield the distal end of the side catheterguide 330. In other instances, the septum puncture device 300 can bedelivered with separation between the side catheter guide 330 and theGSA 350 such that the unshielding step is unnecessary.

With the main shaft 320 extended from the IVC to the SVC, and the GSA350 and guide coupler 340 disposed within the RA, the side catheterguide 330 can be deployed, as shown in FIG. 6B. More specifically, adistal force is applied to a proximal end portion of the side catheterguide 330 such that the force is transferred to the guide coupler,causing the guide coupler 340 to rotate or deflect, resulting inrotation or deflection of a portion of the side catheter guide 330extending distally from the guide coupler 340 about the guide coupler340. In this embodiment, as shown in FIG. 6B, the deflection occurs suchthat the distal end portion of the side catheter guide 330 laterallydeflects about 90 degrees and about perpendicular to the central axis ofthe main shaft 320. In alternative embodiments, the lateral deflectionmay be less than about 90 degrees, such as, for example, about 15degrees, about 30 degrees, about 45 degrees, about 60 degrees, about 75degrees, or any degrees therebetween. In some instances, the lateraldeflection may be about 75 degrees to about 85 degrees, e.g., about 80degrees. In even further embodiments, the lateral deflection may begreater than about 90 degrees, such as, for example, about 105 degrees,about 120 degrees, about 135 degrees, or any degrees therebetween.Although in this embodiment actuation of the side catheter guide 330 issufficient to laterally deflect a portion of the side catheter guide 330such that that portion is about perpendicular to the central axis of themain shaft 320, in other embodiments, for example, in which the lateraldeflection is less than about 90 degrees, additional lateraldeflection/rotation can be applied by the GSA 350, as discussed infurther detail herein.

Next, the GSA 350 is actuated, i.e., in this embodiment, inflated, asshown in FIG. 6C. More specifically, fluid is administered to the GSA350 to inflate the GSA 350. With the GSA 350 inflated, the inflationsection 320B about which the GSA 350 is disposed is telescopedproximally, including withdrawn relative to the proximal section 320Asuch that the proximal side of the GSA 350 is brought into physicalcontact with the side catheter guide 350, as shown in FIG. 6D. Theinflation section 320B can be withdrawn relative to the proximal section320A any distance and with any safely-administrable amount of forcesuitable to sufficiently contact or stabilize the side catheter guide330. In some instances, such withdrawal can apply a force to the sidecatheter guide 330 to further laterally deflect the side catheter guide330 (although as shown and described in this embodiment, the sidecatheter guide 330 is laterally deflected about 90 degrees prior tobeing physically contacted by the GSA 350), resulting in the distal endportion of the side catheter guide 330 being, for example, perpendicularor about perpendicular to the central axis of the main shaft 320 or asurface line tangent to the FO or main shaft 320. Further, suchwithdrawal force causes the GSA 350 to contact or abut the distal endportion of the side catheter guide 330 to stabilize (e.g., laterally,axially (proximally or distally)) relative to the main shaft 320.Although not shown, in some instances, the withdrawal force can besufficient to cause the GSA 350 to become indented with an impression ofthe side catheter guide 330 or envelop a portion of the side catheterguide 330. In this manner, the side catheter guide 330 can besufficiently stabilized and temporarily sufficiently coupled to the GSA350. In some embodiments, the GSA 350 can be configured to possessvariable amounts of compliance. In some embodiments, for example, aproximal portion of the GSA 350 that is configured to contact the sidecatheter guide 330 can have a first level of compliance while anotherportion of the GSA 350 can have a second level of compliance that isdifferent from the first level of compliance. Further, in someembodiments, the proximal side of the GSA 350 can include featuresconfigured to further stabilize the side catheter guide 330 relative tothe GSA 350. These features can include, for example, dimples,protrusions, adhesives, or the like.

With the GSA 350 actuated and in sufficient contact with the sidecatheter guide 330 and providing sufficient stabilization of the sidecatheter guide 330 relative to the main shaft 320, the end effector 362is deployed, as shown in FIG. 6E. To deploy the end effector 362, theside catheter 360 from which the end effector 362 distally extends isadvanced relative to the side catheter guide 330 such that the endeffector 362 is allowed to expand to its expanded/deployed configurationas it is released from its constrained configuration within the lumen ofthe side catheter guide 330.

With the end effector 362 deployed, the end effector 362 can be advancedtowards and into contact with the FO to tent the FO. As describedelsewhere herein, both the end effector and the tenting of the FO (orother portion of the septum) are visible to the operator from outsidethe patient via various imaging technologies, such as, for example,ultrasound or related suitable imaging technologies. To advance the endeffector 362 towards and into contact with the FO, the side catheter 360can be advanced (e.g., by actuating the side catheter actuator, notshown) relative to the side catheter guide 330) or by manipulating(i.e., translating or rotating) the main shaft 320.

In instances in which the operator is not satisfied with the location onthe septum contacted or tented by the end effector 362, e.g., if the endeffector 362 is misaligned with the FO, the end effector 362 can bewithdrawn from contact with the FO or septum (e.g., by withdrawing theside catheter 360 relative to the side catheter guide 330 or bymanipulating the main shaft 320), and then the operator can make anotherapproach at landing the end effector 362 on the FO in a mannersufficient for subsequent puncturing of the FO. This process can berepeated until the operator is satisfied.

With the FO properly tented by the end effector 362, the septumpenetrator 370 can be advanced relative to the side catheter 360 and theend effector 362, and shown in FIG. 6G, and through the FO and into theLA. With the FO sufficiently penetrated by the septum penetrator 370,and a distal end of the septum penetrator 370 disposed within the LA,the guide wire GW2 is advanced relative to and through the lumen definedby the septum penetrator 370 such that at least a distal end portion ofthe guide wire GW2 exits the distal end of the septum penetrator 370 (asshown in FIG. 6H) and advances into the LA, which can be confirmed bythe operator under imaging technologies. Once confirmed that the GW2 issufficiently disposed within the LA, the septum penetrator 370 can bewithdrawn relative to and into the lumen of the side catheter 360, theGSA 350 can be deflated (e.g., into its delivery configuration), and theside catheter guide 330 can be withdrawn into its linear, pre-deployed,delivery configuration, suitable for removal from the patient. Further,in some instances, the end effector 362 can be withdrawn relative to andinto the lumen defined by the side catheter 360.

With the septum penetrator 370 withdrawn from the LA, the operator canmanipulate the septum puncture device 300 (e.g., the handle 380, thebody 310, or the main shaft 320) to withdraw the entire septum puncturedevice 300 along the guide wire GW2 until the septum puncture device 300exits the patient.

FIGS. 7A and 7B further illustrate actuation of or transition of theside catheter guide 340 and the guide coupler 340 between theirrespective delivery (FIG. 7A) and deployed configurations (FIG. 7B). Asshown in FIG. 7A, with the septum puncture device 300 disposed in itsdelivery configuration, the main shaft 320 and the side catheter guide330 extend distally and relatively parallel or about parallel from thebody 310, and are coupled to each other via the guide coupler 340. Morespecifically, the guide coupler 340 is coupled to and between the sidecatheter guide 330 and the proximal section 320A of the main shaft 320.With the guide coupler 340 coupled to the proximal section 320A of themain shaft 320, the inflation section 320B of the main shaft 320 can beadvanced relative to the proximal section 320A, in some instances, forexample, without disturbance to or by the guide coupler 340.

As described in further detail herein, the side catheter guide 340 canbe configured to transition its delivery configuration (FIG. 7A) to itsdeployed configuration (FIG. 7B) in response to a distal force appliedto a portion of the side catheter guide 340 that is disposed proximal tothe guide coupler 340 (e.g., a distal force applied at the handle 380).With a portion of the side catheter guide 340 translationally fixed butrotationally movably coupled to the proximal section 320A of the mainshaft 320 via the guide coupler 340, the side catheter guide 330 isconfigured to deform as shown in FIG. 7B, and such that the portion ofthe side catheter guide 330 that is disposed distal to the guide coupler340 rotates clockwise about the guide coupler 340.

Further, the distal force applied to the side catheter guide 340 causesthe portion of the guide coupler 340 disposed about the side catheterguide 340 to rotate about the portion of the guide coupler 340 that isdisposed about the main shaft 320, as shown in FIG. 7B. Said anotherway, the distal force applied to the side catheter guide 340 istransferred at least in part to the guide coupler 340 such that thehinging feature of the guide coupler 340 is activated to allow the sidecatheter guide 330 to transition from its delivery configuration to itsdeployed configuration.

In this embodiment the guide coupler 340 is formed of suture, and isthreaded or routed about and between both the main shaft 320 and theside catheter guide 330 to limit or prevent relative translationalmovement but allow rotational relative movement between the main shaft320 and the side catheter guide 330, as described in further detailherein. The suture can be threaded or routed about and between the mainshaft 320 and the side catheter guide 330 in any manner suitable toprovide it's intended functionality. In some implementations, a fastenercan be added to the suture to improve its fixation to the main shaft 320and the side catheter guide 330. The fastener, can be, for example, anadhesive, which in some instances, is used to bond the wraps/loops ofsuture and the loose ends of the suture.

FIG. 8 illustrates an example arrangement of the suture (the guidecoupler 340). As shown (at left of FIG. 8), the suture is initiated witha cow hitch 340CH about the side catheter guide 330, and then a firstworking end of the suture is routed in a first direction D1 about themain shaft 320, spiraling or looping about the main shaft 320, and asecond working end of the suture is routed in a second direction D2(opposite the first direction D1) about the main shaft 320, spiraling orlooping about the main shaft 320 in a manner similar to the firstworking end. Each end of the suture can be secured by being tuckedunder, between, or threaded through one or more of the loops, or thesuture can be secured by an additional fastener, such as, for example,an adhesive coating.

FIG. 9 illustrates a method 400 of using the septum puncture device 300to access a left atrium of a heart of a patient, according to anembodiment. At 401, the guide wire GW1 is inserted through the IVC,across the RA, and into SVC of the heart (e.g., via a femoral veinpuncture and through the patient's vasculature disposed between thefemoral vein puncture site and the IVC). At 402, the septum puncturedevice 300 is delivered over the guide wire GW1 until the distal end ofa main shaft 320 is disposed within the SVC. In some instances, theguide wire GW1 can be advanced or wedged into the uppermost aspect ofthe SVC (e.g., the bifurcation of the SVC into the right and leftbrachiocephalic (innominate) veins, to provide additional stability forthe main shaft 320 and associated components (e.g., side catheter guide330). At 404, the side catheter guide 330 is actuated to direct a distalend of the side catheter guide 330 towards a FO of a septum of theheart. At 406, the GSA 350 that is disposed about the main shaft 320 isinflated, and the inflation section 320B of the main shaft 320 iswithdrawn relative to the proximal section 320B of the main shaft 320such that the GSA 350 abuts the side catheter guide 330.

At 408, optionally, the main shaft 320 and the side catheter guide 330are fine positioned (e.g., translated, rotated, etc.) relative to theFO. At 410, the side catheter 360 is advanced and the end effector 362is deployed from a distal end portion of the side catheter guide 330such that the side catheter 360 contacts and tents the FO. At 412,optionally, an operator visualizes the tenting of the FO. At 414, theseptum penetrator 370 is advanced relative to the side catheter 360through the FO and into the LA. At 416, optionally, an operatorvisualizes the septum penetrator 370 to confirm that the septumpenetrator 370 crossed into the LA. At 418, the second guide wire GW2 isadvanced relative to the septum penetrator 370 into the LA. At 420, theseptum penetrator 370 is withdrawn relative and into a lumen defined bythe side catheter 360, the inflation section 320B of the main shaft 320is advanced relative to the proximal section 320A, the side catheterguide 330 is withdrawn relative to the main shaft 320, and the balloonis deflated. Optionally, at 420, the end effector 362 is withdrawnrelative to the side catheter guide 330. In some instances, withdrawingthe end effector 362 relative to the side catheter guide 330 includeswithdrawing the end effector 362 into the lumen defined by the sidecatheter guide 330 to place the end effector 362 back into its deliveryconfiguration.

Although the septum puncture device 300 is shown and described as havingthe GSA 350, in alternative embodiments, for example, a septum puncturedevice could be similar to the septum puncture device 300, but notinclude a GSA. In such embodiments, the septum puncture device could,for example, rely on the guide coupler for both lateral deflection andstabilization of the side catheter guide, side catheter, and septumpenetrator. FIGS. 7A and 7B can be referred to as an illustrativeexample of such an alternative embodiment, given that these figures showonly a portion of the septum puncture device 300, not including the GSA350.

FIGS. 10-12 illustrate in perspective bottom view, perspective sideview, and side view, respectively a portion of a septum puncture device500 in a deployed configuration, according to another embodiment.Similar to or the same as described with respect to other septumpuncture devices described herein (e.g., septum puncture device 100,septum puncture device 300, etc.), the septum puncture device 500 can beused to access a left side of the heart (e.g., left atrium) from theright side of the heart (e.g., right atrium) and to deliver a guidewireto the left side of the heart. The septum puncture device 500 can beconstructed the same as or similar to, and can function the same as orsimilar to, any of the septum puncture devices described herein. Thus,portions of the septum puncture device 500 are not described in furtherdetail herein.

In this embodiment, as shown, the septum puncture device 500 includes amain shaft 520 that defines a lumen therethough (e.g., through which aguide wire can be routed). The main shaft 520 includes a proximalsection 520A at its proximal end, a distal section 520C at its distalend, and an inflation section 520B disposed therebetween. The proximalsection 520A defines a first aperture AP1, and the inflation section520B defines a second aperture AP2 and a third aperture AP3 disposedopposite the second aperture AP2, both in fluid communication with thelumen of the main shaft 520. As shown best in FIG. 12, in thisembodiment, a proximal end of the inflation section 520B is insertedinto the proximal section 520A, and a distal end of the inflationsection 520B is inserted into the distal section 520C. In alternativeembodiments, however, other main shaft designs suitable to providestability for lateral puncture can be used. In some embodiments, forexample, two or three of the proximal section, inflation section, distalsection can be monolithically formed, rather than formed separated andthen coupled together.

The septum puncture device 500 further includes a side catheter guide530 that extends distally into the lumen of the main shaft 520 at aproximal end of the proximal section 520A of the main shaft 520, out thefirst aperture AP1 (see e.g., FIG. 11), towards and into the secondaperture AP2, and out the third aperture AP3, as shown.

The inflation section 520B of the main shaft 520 defines (1) a firstinflation portion 526A about which a first stabilizer/actuator guide(“GSA”) 550A is disposed, and (2) a second inflation portion 526B aboutwhich a second stabilizer/actuator guide (“GSA”) 550B is disposed. Inthis embodiment, the first GSA 550A and the second GSA 550B are balloonsdisposed circumferentially about the main shaft 520. A distal portion ofthe side catheter guide 530 can be translationally coupled (relative tothe main shaft 520) directly to the main shaft 520 between the first GSA550A and the second GSA 550B (e.g., using any suitable fastener), or thedistal portion of the side catheter guide 530 can be translationallyfixed relative to the main shaft 520 by way of contact, abutment,interference fit, etc., from the distal side surface of the first GSA550A and the proximal side surface of the second GSA 550B. In someimplementations, the distal portion of the side catheter guide 530 canbe fastened to one or both of the first GSA 550A or second GSA 550B.

The first GSA 550A and the second GSA 550B are configured to be inflatedfor deployment and deflated for delivery or withdrawal. To inflate, thefirst GSA 550A is configured to receive one or more fluids (e.g., one ormore of saline, air, or a contrast agent for visualization) from andthrough an opening O (FIG. 12) defined by the first inflation portion526A; and similarly, the second GSA 550B is configured to receive one ormore fluids from and through an opening O (FIG. 12) defined by thesecond inflation portion 526B. In use, for example, one or more fluidscan be conveyed through the lumen of the main shaft 320 and into avolume defined by the first GSA 550A (via the opening O in the firstinflation portion 526A) and into a volume defined by the second GSA 550B(via the opening O in the second inflation portion 526B). The samefluid(s) can be withdrawn from the first GSA 550A and the second GSA550B (e.g., via the same pathway used to deliver the fluid(s)) todeflate the first GSA 550A and the second GSA 550B such that thecross-sectional area or footprint of the first GSA 550A and the secondGSA 550B is reduced to facilitate removal from the patient. The balloonscan be any size suitable to perform that desired functionality disclosedherein, for example, in some embodiments, the balloons can be 20 mm orabout 20 mm in diameter when inflated. In some implementations of thisembodiment, the septum puncture device 500 can include a GSA actuator(not shown, but e.g., disposed at or operably coupled to a handle of theseptum puncture device, which is also not shown) configured to inflateor deflate the first GSA 550A and the second GSA 550B.

As shown, and similar to other embodiments described herein, routing theside catheter guide 530 distally around the first GSA 550A and thenthrough a pathway defined by and between the first GSA 550A and thesecond GSA 550B, the side catheter guide 530 assumes a curve such that alength of the side catheter guide 530 extends from beyond a first sideof the main shaft 520 to beyond a second side of the main shaft 520(e.g., at least a distance equal to a diameter of the first GSA 550A orthe second GSA 550B, when inflated), thereby providing a suitablestraight or substantially straight length (e.g., about 3 cm to about 4cm in some instances) to house a septum penetrator (or a rigid portionof the septum penetrator), as described in further detail herein withrespect to other embodiments.

As recited above, some components of the septum puncture device 500 aresimilar to or the same as (in form or function) components from otherseptum puncture devices described herein, and some of those componentsare not described or illustrated again with respect to the septumpuncture device 500. For example, in some embodiments, the septumpuncture device 500 includes a body, a handle, a side catheter (with orwithout an end effector extending therefrom), a septum penetrator, guidewire coupler(s), or actuators (e.g., shaft actuator, GSA actuator, sidecatheter actuator, penetrator actuator), none of which are illustratedin FIGS. 10-12. The following example method of using the septumpuncture device 500 refers to some of those components.

In use, for example and similar to as described herein with respect toother embodiments, the septum puncture device 500 can be inserted intothe patient (e.g., via a femoral vein puncture), through the patient'svasculature, and into the heart of the patient such that the main shaft520 spans the IVC, RA, and SVC to provide a stable platform againstwhich the septum puncture device 300 can be deployed to puncture the FO.In some instances, the septum puncture device 500 can be inserted over aguide wire (not shown) that is routed through the lumen of the mainshaft 520 (or in some instances, through a guide wire coupler, notshown). During such delivery, the septum puncture device 500 is in itsdelivery configuration in which the first GSA 550A and the second GSA550B deflated (not shown). In this manner, for example, thecross-sectional area or footprint of the septum puncture device 500 canbe minimized or optimized for minimally-invasive delivery through thepatient.

With the main shaft 520 extended from the IVC to the SVC, and the firstGSA 550A, the second GSA 550B, and the distal end portion of the sidecatheter guide 530 disposed within the RA, the first GSA 550A and thesecond GSA 550B can be inflated to deploy the side catheter guide 530,as shown in FIGS. 10-12. Inflating the first GSA 550A and the second GSA550B in this manner causes the distal end portion of the side catheterguide 530 (1) to laterally deflect to a preferred angle and towards theFO, and (2) to stabilize the distal end portion of the side catheterguide 530, to facilitate subsequent tenting or puncturing of the FO. Inthis embodiment, as shown in FIG. 11, the deflection occurs such thatthe distal end portion of the side catheter guide 530 laterally deflectsto perpendicular or about perpendicular to a central axis of the mainshaft 520 or to a surface line tangent to the FO or the main shaft 520.In alternative embodiments, as described with respect to otherembodiments, the lateral deflection may selectively be less than aboutor greater than about 90 degrees. Although not shown, in some instances,the first GSA 550A or the second GSA 550B can be inflated such that thefirst GSA 550A or the second GSA 550B become indented with an impressionof the distal end portion of the side catheter guide 530 or envelop aportion of the same. In this manner, the side catheter guide 530 can besufficiently stabilized and temporarily sufficiently coupled to thefirst GSA 550A or the second GSA 550B. In some embodiments, the GSA 550Aor the GSA 550B can be configured to possess variable amounts ofcompliance. In some embodiments, for example, a distal portion of thefirst GSA 550A and a proximal portion of the second GSA 550B can have afirst level of compliance while another portion of the first GSA 550Aand another portion of the second GSA 550B can have a second level ofcompliance that is different from the first level of compliance.Further, in some embodiments, the distal side of the first GSA 550A andthe proximal side of the second GSA 550B can include features configuredto further stabilize the side catheter guide 530 relative to the GSA550. These features can include, for example, dimples, protrusions,adhesives, or the like.

With the first GSA 550A and the second GSA 550B actuated and insufficient contact with the side catheter guide 530 and providingsufficient stabilization of the side catheter guide 530 relative to themain shaft 520, an end effector (not shown) can be deployed from theside catheter guide 530, similar to or the same as described in otherembodiments. To deploy the end effector, for example, a side catheter(not shown) from which the end effector distally extends can be advancedrelative to the side catheter guide 530 (e.g., through a lumen definedby and extending through the side catheter guide 530) such that the endeffector is allowed to expand to its expanded/deployed configuration asit is released from its constrained or delivery configuration within thelumen of the side catheter guide 530.

With the end effector deployed, the end effector can be advanced towardsand into contact with the FO to tent the FO. As described elsewhereherein, both the end effector and the tenting of the FO (or otherportion of the septum) are visible to the operator from outside thepatient via various imaging technologies, such as, for example,ultrasound or related suitable imaging technologies. To advance the endeffector towards and into contact with the FO, the side catheter can beadvanced (e.g., by actuating a side catheter actuator, not shown)relative to the side catheter guide 530) or by manipulating (i.e.,translating or rotating) the main shaft 520.

In instances in which the operator is not satisfied with the location onthe septum contacted or tented by the end effector, e.g., if the endeffector is misaligned with the FO, the end effector can be withdrawnfrom contact with the FO or septum (e.g., by withdrawing the sidecatheter relative to the side catheter guide 530 or by manipulating themain shaft 520), and then the operator can make another approach atlanding the end effector on the FO in a manner sufficient for subsequentpuncturing of the FO. This process can be repeated until the operator issatisfied.

With the FO properly tented by the end effector, the septum penetrator(not shown) can be advanced relative to the side catheter (e.g., througha lumen defined by and extending through the side catheter) and the endeffector, and through the FO and into the LA. With the FO sufficientlypenetrated by the septum penetrator, and a distal end of the septumpenetrator disposed within the LA, a second guide wire can advancedrelative to and through a lumen defined by and extending through theseptum penetrator such that at least a distal end portion of the guidewire exits the distal end of the septum penetrator and advances into theLA, which can be confirmed by the operator under imaging technologies.

Once confirmed that the second guide wire is sufficiently disposedwithin the LA, the septum penetrator can be withdrawn relative to andinto the lumen of the side catheter, the first GSA 550A and the secondGSA 550B can be deflated, in preparation for removal of the septumpuncture device 500 from the patient. Further, in some instances, theend effector can be withdrawn relative to and into the lumen defined bythe side catheter.

With the septum penetrator withdrawn from the LA, the operator canmanipulate the septum puncture device 500 (e.g., the handle, the body,or the main shaft 520) to withdraw the entire septum puncture device 500along the second guide wire until the septum puncture device 500 exitsthe patient, leaving the second guide wire within the patient forsubsequent access to the left atrium (e.g., without further penetrationof the FO).

In some implementations, during delivery, the side catheter guide 530(or any components disposed therein) can be protected from deploying oradvancing prematurely or from inadvertently undesirably contacting thepatient's anatomy. In some instances, for example, the side catheterguide 530 (or side catheter and end effector extending or protrudingfrom the distal end of the side catheter guide 530) can be at leastpartially encased within the first GSA 550A and the second GSA 550B, intheir delivery, or deflated configurations. As an example illustration,FIGS. 13A-13F show a partial delivery and deployment sequence. FIG. 13Ashows the septum puncture device 500 in a delivery configuration inwhich the first GSA 550A and the second GSA 550B are deflated anddisposed circumferentially about the side catheter guide 530. FIG. 13Bshows the first GSA 550A and the second GSA 550B in deployed, inflatedconfigurations, in which the side catheter guide 530 is laterallydeflected relative to the main shaft 520 such that a distal end of theside catheter guide 530 is directed towards the FO, and extendsproximally in a linear fashion between the first GSA 550A and the secondGSA 550B, towards and beyond the main shaft 520. Arrow L and arrow Rrepresent a linear axis and an angular axis, respectively, along whichthe main shaft 520 can be adjusted by the operator to align the distalend of the side catheter guide (or end effector of the side catheter)with the FO.

FIG. 13C shows the side catheter 560 with end effector 562 advanced fromthe side catheter guide 530 and in contact with and tenting the FO. Theside catheter 560 can be advanced any suitable distance to probe the FO.In some instances, for example, the side catheter 560 can advance about1 cm to about 4 cm from the side catheter guide 530. In other instances,as another example, the side catheter 560 can advance about 2 cm toabout 3 cm from the side catheter guide 530.

FIG. 13D shows the septum penetrator 570 advanced from the side catheter560, through the FO and into the LA, and a guide wire GW2 (with apigtail configuration) advanced from the septum penetrator 570 throughthe FO and into the LA. The septum penetrator 570 can be advanced anysuitable distance from the side catheter 560 to penetrate the FO andenter the LA. In some instances, for example, the septum penetrator 570can be advanced about 0.5 cm to about 1 cm from the side catheter 560.

With the guide wire GW2 disposed within the LA, the septum penetrator570 can be withdrawn from the LA, as described in more detail herein,and as shown in FIG. 13E. Further, as shown in FIG. 13F, the first GSA550A and the second GSA 550B can be deflated, and the septum puncturedevice 500 can be withdrawn relative to and along the guide wire GW2,leaving the guide wire GW2 extending from within the LA, through thepuncture in the FO, into the LA, and through the patient's vasculatureand out of the patient, for subsequent minimally-invasive access to theLA.

Although the septum puncture device 500 is shown and described as havingthe second aperture AP2 and third aperture AP3 in the main shaft 520through which the side catheter guide 530 can be disposed, in otherembodiments, a similar septum puncture device could include a sidecatheter guide that extends or is routed along an exterior surface ofthe main shaft, rather than through the main shaft. In such embodiments,for example, the septum puncture device can include a guide coupler thatis similar to or the same as, in form or function, to any of the guidecouplers described herein with respect to other embodiments. The guidecoupler, for example, can be disposed between a first GSA and a secondGSA, and used to couple (e.g., translationally fixedly couple, androtatably couple) the side catheter guide to the main shaft, such thatthe side catheter guide can laterally deflect about the guide coupler inresponse to the inflation/deployment of the first GSA and the secondGSA. The guide coupler, in some implementations, can be a hinge, such asa hinge formed of suture, similar to or the same as described herein inother embodiments.

Although the septum puncture device 500 is shown and described as havinga side catheter guide 530 through which the side catheter 560 (and endeffector 562), septum penetrator 570, and guide wire GW2 can be slidablydisposed, in alternative embodiments, a septum puncture device can, forexample, not include a side catheter guide. FIGS. 14A-14K illustratesuch an alternative embodiment. More specifically, FIGS. 14A-14Killustrate an example deployment sequence of and at a distal end portionof a septum puncture device 600, according to an embodiment.

Similar to or the same as described with respect to other septumpuncture devices described herein, the septum puncture device 600 can beused to access a left side of the heart (e.g., left atrium) from theright side of the heart (e.g., right atrium) and to deliver a guidewireto the left side of the heart. The septum puncture device 600 can beconstructed the same as or similar to, and can function the same as orsimilar to, any of the septum puncture devices described herein. Thus,portions of the septum puncture device 600 are not described in furtherdetail herein.

In this embodiment, as shown in FIG. 14A, prior to deployment, theseptum puncture device 600 has a protective sleeve 629 coupled to andcircumferentially disposed about a portion of the main shaft 620, thefirst GSA 650A, the second GSA 650B, and a portion of the side catheter660. The protective sleeve 629, for example, can shield theaforementioned components of the septum puncture device 600 prior to useof the septum puncture device 600. In such instances, the protectivesleeve 629 could be removed prior to insertion of the septum puncturedevice 600 into the patient. Further, in some instances, the protectivesleeve 629 can shield the aforementioned components of the septumpuncture device 600 during delivery of the septum puncture device 600into and through the patient. As an example, the septum puncture device600 could be inserted into the patient's vasculature, through the IVCand into the RA, similar to as described herein with respect to otherembodiments. In such instances, the protective sleeve 629 can beconfigured to prevent inadvertent contact or trauma to the patient'ssurrounding tissue. Additionally, or alternatively, the protectivesleeve 629 can be configured to constrain the first GSA 650A, the secondGSA 650B, or the side catheter 660 to define a cross-sectional profileor footprint suitable to be delivered through the patient. In thismanner, the protective sleeve 629, and components disposed therein,could be delivered to the RA of the heart, and then the protectivesleeve 629 can be withdrawn along the main shaft 620 (or in someinstances advanced along the main shaft 620) to expose the first GSA650A, the second GSA 650B, and a portion of the side catheter 660.

With the protective sleeve 629 withdrawn or advanced, the side catheter630 can assume it's curved orientation, as described herein in otherembodiments and as shown in FIG. 14B. Further, as shown in FIG. 14B, insome instances the end effector 662 can be disposed between the firstGSA 650A and the second GSA 650B such that the end effector 662 is atleast partially shielded. Said another way, the end effector 662 isspaced a distance from the central axis of the main shaft 620 that isless than a radius of the first GSA 650A and the second GSA 650B.Further, the side catheter 660 is slidably disposed relative to the mainshaft 620 and the first GSA 650A and the second GSA 650B. As such, theside catheter 660 (and end effector 662) can be advanced relative to themain shaft 620 to provide sufficient space within which the first GSA650A and the second GSA 650B can expand or inflate, as shown in FIG.14C.

With the end effector 662 advanced in this manner, the first GSA 650Aand the second GSA 650B are inflated, as shown in FIG. 14D. Also, asshown, inflation of the first GSA 650A and the second GSA 650B causesthe distal end portion of the side catheter 660 to laterally deflect andto stabilize with respect to the main shaft 620. The lateral deflectionwas measured during an experiment, and the measurement is shown in FIGS.14E and 14F as an illustrative example. As shown in FIG. 14E, prior toinflation of the first GSA 650A and the second GSA 650B, an anglebetween (1) a central axis of the portion of the side catheter 660extending distally from (a) the central axis of the main shaft 620 and(b) the first GSA 650A and the second GSA 650B, and (2) the central axisof the main shaft 620, is between about 65 to about 70 degrees. Uponinflation of the first GSA 650A and the second GSA 650B, that anglechanges to about 90 degrees, as shown in FIG. 14F.

With the side catheter 660 laterally deflected in this manner, the sidecatheter 660 optionally can be advanced further relative to the mainshaft 620 such that the effective length (e.g., the length of the sidecatheter extending distally from the closest external surfaces of thefirst and second GSA 650A, 650B) is increased to a desirable amount fortenting of the FO, as shown in FIG. 14G. Next, the septum penetrator 670can be advanced relative to the end effector 662, as shown in FIG. 14H,to, for example, penetrate the FO. Further, and as described herein inother embodiments, a guide wire GW2 can be advanced through a lumendefined by the septum penetrator 670 and relative to the end effector662, as shown in FIG. 14I.

With the guide wire GW2 sufficiently advanced, the septum penetrator 670can be withdrawn into the lumen defined by the side catheter 670 (e.g.,to prevent any inadvertent contact (and risk of damage) between a sharpedge of the septum penetrator 670 and the guide wire GW2, and the sharpedge of the septum penetrator 670 and the patient's surrounding anatomy,as shown in FIG. 14J. Further, as shown in FIG. 14J, the first GSA 650Aand the second GSA 650B can be deflated, and the side catheter (and endeffector 662) can be withdrawn about the guide wire GW2, relative to themain shaft 620, and towards its delivery position, as shown in FIG. 14K.

Although (1) the septum puncture device 500 is shown and described ashaving a side catheter guide 530 routed through a lumen defined by themain shaft 520 (or a central axis of the main shaft 520), or morespecifically, into the second aperture AP2 and out of the third AP3 ofthe main shaft 520, and (2) the septum puncture device 600 is shown anddescribed as having a side catheter 660 routed through a lumen orcentral axis of the main shaft 620, in other embodiments, a sidecatheter guide or side catheter can be routed along an external surfaceof the main shaft, i.e., offset from the central axis of the main shaft.The side catheter guide or side catheter, from top view, for example,can be disposed to one side of the main shaft. Offsetting the sidecatheter guide or side catheter relative to the central axis of the mainshaft in this manner in many instances better aligns the distal end ofthe side catheter guide or side catheter with the FO, given the commonanatomical location of the FO relative to the IVC, SVC, and RA (e.g.,measured laterally from a central longitudinal axis from the IVC to theSVC). The FO is often offset from a central axis defined from the IVC tothe SVC by about 4 mm to about 6 mm, so aligning the side catheter guidea comparable distance offset from the central axis of the main shaft,may in some instances, place the side catheter guide or side catheter ina more suitable position for subsequent puncture. In this manner, thearrangement of the side catheter guide or side catheter with the mainshaft can optimize the time and number of steps required of the operatorto locate the FO with the side catheter (or end effector), forsubsequent puncturing of the FO with the septum penetrator.

One such example is illustrated in FIGS. 15-17, which show a septumpuncture device 700 in a perspective view, front view, and side view,respectively, according to an embodiment. Similar to or the same asdescribed with respect to other septum puncture devices describedherein, the septum puncture device 700 can be used to access a left sideof the heart (e.g., left atrium) from the right side of the heart (e.g.,right atrium) and to deliver a guidewire to the left side of the heart.The septum puncture device 700 can be constructed the same as or similarto, and can function the same as or similar to, any of the septumpuncture device described herein. Thus, portions of the septum puncturedevice 700 are not described in further detail herein.

In this embodiment, the septum puncture device 700 includes a main shaft720, a first GSA 750A, a second GSA 750B, and a side catheter 760 routedaround or about the first GSA 750A and then between the first GSA 750Aand the second GSA 750B, and along an external surface of the main shaft720 (and offset from the central axis of the main shaft 720), as shown.In this manner, in some instances, the side catheter 760 can be betteraligned with the FO of the patient. Although not shown in FIGS. 15-17,in some implementations, the side catheter 760 can be slidably attachedvia a guide coupler (not shown) to the main shaft 720. The guidecoupler, for example, can be configured to slidably and rotatably attachthe side catheter 760 to the main shaft 720 to prevent the side catheter760 from separating from the main shaft 720 or from between the firstGSA 750A and the second GSA 750B. In other implementations, for example,the guide coupler can be attached to, part of, or extend from the firstGSA 750A or the second GSA 750B. An illustrated example of a guidecoupler 840 of a septum puncture device 800 is shown in FIGS. 18A-18C,according to an embodiment.

Similar to or the same as described with respect to other septumpuncture devices described herein, the septum puncture device 800 can beused to access a left side of the heart (e.g., left atrium) from theright side of the heart (e.g., right atrium) and to deliver a guidewireto the left side of the heart. The septum puncture device 800 can beconstructed the same as or similar to, and can function the same as orsimilar to, any of the septum puncture device described herein. Thus,portions of the septum puncture device 700 are not described in furtherdetail herein.

FIGS. 18A-18C illustrate the first GSA 850A and the second GSA 850B in adeflated, delivery configuration (in which the side catheter 860 is atleast partially axially aligned with the main shaft 820), a partiallyinflated, partially deployed configuration (in which the side catheter860 has been laterally deflected a first number of degrees), and aninflated, deployed configuration (in which the side catheter 860 hasbeen laterally deflected a second number of degrees that is greater thanthe first number of degrees, stabilized, and directed towards therepresentative model of a FO), respectively.

As shown, the guide coupler 840 in this embodiment extends from the mainshaft 820 and circumferentially surrounds or engages the side catheter860. More specifically, the guide coupler 840 defines an eyelet throughwhich the side catheter 860 is threaded. In this manner, the sidecatheter 860 has freedom to translate (advance or be withdrawn) throughthe eyelet. In some implementations, the eyelet can be sized to have atleast a partial interference fit, thereby providing some frictionbetween the guide coupler 840 and the side catheter 860 such that theside catheter 860 isn't inadvertently translated. Further, the guidecoupler 840 is configured to rotate about the main shaft 820 in responseto inflation of the first GSA 850A and the second GSA 850B, to allow theside catheter 860 to laterally deflect towards its target location(e.g., the FO), as shown in FIG. 18C. After delivery of a guide wire GW2(not shown), as discussed herein with respect to other embodiments, thefirst GSA 850A and the second GSA 850B can be deflated and the guidecoupler 840 can be rotated in a direction opposite to the direction itrotated during deployment.

Although various embodiments of septum puncture devices described hereindisclose having a single side catheter guide or single side catheter(with single end effector), in some embodiments, a septum puncturedevice can include two side catheter guides or two side catheters (withor without the side catheter guide(s)). Such an embodiment isillustrated in FIGS. 19-21. FIGS. 19-21 illustrate a septum puncturedevice 900 in perspective view, front view, and detailed, partialperspective view, respectively, that includes a two side catheters.

Similar to or the same as described with respect to other septumpuncture devices described herein, the septum puncture device 900 can beused to access a left side of the heart (e.g., left atrium) from theright side of the heart (e.g., right atrium) and to deliver a guidewireto the left side of the heart. The septum puncture device 900 can beconstructed the same as or similar to, and can function the same as orsimilar to, any of the septum puncture device described herein. Thus,portions of the septum puncture device 900 are not described in furtherdetail herein.

In this embodiment, the septum puncture device 900 includes a first sidecatheter 960A and second side catheter 960B, each being configured to bedelivered and deployed within a patient, as described herein withrespect to other embodiments. The septum puncture device 900 furtherincludes a first end effector 962A extending from the first sidecatheter 960A and a second end effector 962B extending from the secondside catheter 960B. As shown, the main shaft 920 defines a lumen throughwhich the first side catheter 960A and the second side catheter 960B canbe slidably disposed, and an aperture AP through which the first sidecatheter 960A and the second side catheter 960B can be advanced orwithdrawn. The septum puncture device 900 further includes a first GSA950A disposed circumferentially about the main shaft 920 and proximal tothe aperture AP, and a second GSA 950B disposed circumferentially aboutthe main shaft 920 and distal to the aperture AP. In this manner, thefirst side catheter 960A and the second side catheter 960B can extenddistally from the AP and through a pathway defined between the first GSA950A and the second GSA 950B.

In use, similar to as described herein with respect to otherembodiments, the first GSA 950A and the second GSA 950B can be inflatedto laterally deflect and stabilize (e.g., laterally, axially(proximally, distally)) the first side catheter 960A and the second sidecatheter 960B, such that a first and second septum penetrator (notshown) can be advanced or withdrawn there through, and a first andsecond guide wire (not shown), can be advanced and withdrawn via thefirst and second septum penetrator. In accessing the LA, for example,with the first GSA 950A and the second GSA 950B disposed within the RAin inflated, deployed configurations, and the first side catheter 960Aand the second side catheter 960B directed towards the septum, the firstside catheter 960A and the second side catheter 960B can be advanced totent the FO, and then the first and second septum penetrators can beadvanced (optionally simultaneously) to pierce the FO, or other targetlocation(s) of the septum. The puncture sites can be separated by apredefined distance, set by a distance between the side catheter lumens.With two punctures in the septum, two guide wires can then be advanced(optionally simultaneously) into the LA, one through each puncture.

Although the septum puncture device 900 is shown and described as havingtwo GSAs, in other embodiments, a septum puncture device can be similarto or the same as the septum puncture device 900, but include only asingle GSA. An example embodiment is shown in FIGS. 22 and 23, in whicha septum puncture device is shown in front view and perspective view,respectively. Similar to or the same as described with respect to otherseptum puncture devices described herein, the septum puncture device1000 can be used to access a left side of the heart (e.g., left atrium)from the right side of the heart (e.g., right atrium) and to deliver twoguidewires to the left side of the heart. The septum puncture device1000 can be constructed the same as or similar to, and can function thesame as or similar to, any of the septum puncture device describedherein. Thus, portions of the septum puncture device 1000 are notdescribed in further detail herein.

In this embodiment, the septum puncture device 1000 includes a firstside catheter 1060A and second side catheter 1060B, each beingconfigured to be delivered and deployed within a patient, as describedherein with respect to other embodiments. The septum puncture device1000 further includes a first end effector 1062A extending from thefirst side catheter 1060A and a second end effector 1062B extending fromthe second side catheter 1060B. As shown, the main shaft 1020 defines alumen through which the first side catheter 1060A and the second sidecatheter 1060B can be slidably disposed, and an aperture AP throughwhich the first side catheter 1060A and the second side catheter 1060Bcan be advanced or withdrawn. The septum puncture device 1000 furtherincludes a GSA 1050 disposed circumferentially about the main shaft 1000and distal to the aperture AP. In this manner, the first side catheter1060A and the second side catheter 1060B can extend distally from the APand along a proximal end surface of the GSA 1050, as shown.

Although not shown, with the GSA 1050 in its deflated, deliveryconfiguration, the first side catheter 1060A and the second sidecatheter 1060B can be orientated in a more delivery-friendly position,e.g., about parallel to the central axis of the main shaft 1020, alongan external surface of the deflated GSA 1050. As described in furtherdetail herein with respect to other embodiments, the GSA 1050 can beconfigured to be inflated or deployed to laterally deflect the firstside catheter 1060A and the second side catheter 1060B relative to themain shaft 1020, as shown in FIGS. 22 and 23. As described in furtherdetail herein with respect to other embodiments, the GSA 1050 can alsobe configured to stabilize the first side catheter 1060A and the secondside catheter 1060B relative to the main shaft 1020. In someimplementations, for example, the GSA 1050 can include dimples,protrusions, ridges, adhesives, etc., configured to improvestabilization of the first side catheter 1060A and the second sidecatheter 1060B.

With the first side catheter 1060A and the second side catheter 1060Blaterally deflected and stabilized in this manner, the first sidecatheter 1060A and the second side catheter 1060B can be advancedrelative to the main shaft 1020 and towards a target tissue (e.g., theseptum, or FO), and a first septum penetrator, a second septumpenetrator, a first guide wire, and a second guide wire (none of whichare shown in FIGS. 19 and 20) can be deployed, e.g., to penetrate theseptum and delivery the first guide wire and the second guide wire.

Although the septum puncture device 1000 is shown and described ashaving two side catheters, in other embodiments, a septum puncturedevice can be similar to or the same as the septum puncture device 1000,but include only a single GSA. An example embodiment is shown in FIGS.24 and 25, in which a septum puncture device is shown in perspectivefront view and perspective side view, respectively. Similar to or thesame as described with respect to other septum puncture devicesdescribed herein, the septum puncture device 1100 can be used to accessa left side of the heart (e.g., left atrium) from the right side of theheart (e.g., right atrium) and to deliver two guidewires to the leftside of the heart. The septum puncture device 1100 can be constructedthe same as or similar to, and can function the same as or similar to,any of the septum puncture device described herein. Thus, portions ofthe septum puncture device 1100 are not described in further detailherein.

In this embodiment, the septum puncture device 1100 includes a sidecatheter configured to be delivered and deployed within a patient, asdescribed herein with respect to other embodiments. The septum puncturedevice 1100 further includes an end effector 1162 extending from theside catheter 1160. As shown, the main shaft 1120 defines a lumenthrough which the side catheter 1160 and the second side catheter 1160can be slidably disposed, and an aperture AP through which the sidecatheter 1160 and the second side catheter 1160 can be advanced orwithdrawn. The septum puncture device 1100 further includes a GSA 1150disposed circumferentially about the main shaft 1100 and distal to theaperture AP. In this manner, the side catheter 1160 can extend distallyfrom the AP and along a proximal end surface of the GSA 1150, as shown.

Although not shown, with the GSA 1150 in its deflated, deliveryconfiguration, the side catheter 1160 can be orientated in a moredelivery-friendly position, e.g., about parallel to the central axis ofthe main shaft 1120, along an external surface of the deflated GSA 1150.As described in further detail herein with respect to other embodiments,the GSA 1150 can be configured to be inflated or deployed to laterallydeflect the side catheter 1160 relative to the main shaft 1120, as shownin FIGS. 24 and 25. As described in further detail herein with respectto other embodiments, the GSA 1150 can also be configured to stabilizethe side catheter 1160 relative to the main shaft 1120. In someimplementations, for example, the GSA 1150 can include dimples,protrusions, ridges, adhesives, etc., configured to improvestabilization of the first side catheter 1160.

With the side catheter 1160 laterally deflected and stabilized in thismanner, the side catheter can be advanced relative to the main shaft1120 and towards a target tissue (e.g., the septum, or FO), and a firstseptum penetrator, a second septum penetrator, a first guide wire, and asecond guide wire (none of which are shown in FIGS. 24 and 25) can bedeployed, e.g., to penetrate the septum and delivery the first guidewire and the second guide wire.

An example delivery and deployment of the septum puncture device 1100 inthe context of a heart of a patient is shown in FIGS. 26A and 26B. Asshown in FIG. 26A, the septum puncture device 1100 can be disposedwithin the RA of the heart, such that the main shaft 1120 spans the IVC,RA, and SVC, and the GSA 1150 and the side catheter 1160 are disposedwithin the RA. As described in further detail herein with respect toother embodiments, the GSA 1150 can be inflated into its deployedconfiguration to laterally deflect and stabilize the side catheter 1160relative to the main shaft 1120 and towards the FO, as shown in FIG.26B. Further as shown in FIG. 26B, the side catheter 1160 can beadvanced such that the end effector 1162 contacts or tents the FO, afterwhich the septum penetrator 1170 can be advanced relative to anddistally from the end effector 1162, and the guide wire GW2 can beadvanced into the LA.

Although various embodiments of septum puncture devices are describedherein as having one or more GSAs, some of which can be a balloon,having a particular shape, size, etc., any of the embodiments describedherein can be modified to have one or more GSAs having any shape, size,inflation volume, material(s), surface feature(s), etc. suitable to beinflatably and deflatably coupled to a main shaft, and to laterallydeflect and stabilize one or more side catheter guides or one or moreside catheters (and any components disposed therein, such as, forexample, end effectors, septum penetrators, and guide wires). Variousembodiments of GSAs, as illustrative examples, are described below withrespect to FIGS. 27-34, and referred to as being part of septum puncturedevices 1200-1900, all of which can be the same has or similar to, andfunction the same as or similar to, other septum puncture devicesdescribed herein. Thus, portions of the septum puncture devices1200-1900 are not described in further detail herein.

In some embodiments, for example, a GSA can have a concave or a convexshape. One such embodiment is illustrated in FIG. 27, which shows aportion of a septum puncture device 1200 including a first GSA 1250Ahaving a concave shape at its distal end, and a second GSA 1250B,disposed distal to the first GSA 1250A, and having a convex shape at itsproximal end. As shown, such a combination of shapes can define apathway through which the side catheter 1260 can be slidably disposed(or through which a side catheter guide can be disposed, in alternativeembodiments).

In another embodiment, a GSA can be configured to define an optimalpathway along which a side catheter guide or side catheter can extendfrom a proximal end of the GSA to a distal end of the GSA. One suchembodiment is illustrated in FIG. 28, which shows a portion of a septumpuncture device 1300 including a first GSA 1350A having a particularcurve C along which the side catheter 1360 (or side catheter guide inother implementations) can extend and engage with the first GSA. Asshown, in this embodiment, the curve C is different from thecorresponding section of the second GSA 1350B.

In some embodiments, a septum puncture device can include one or moreGSAs with multiple lobes (bi-lobed, tri-lobed, etc.). Multiple lobes,for example, can reduce or limit the footprint of the GSAs, therebyreducing the risk of undesirable occlusion within the patient. Ininstances in which the GSAs are disposed within a patient's RA, forexample, it may be advantageous to minimize the cross-sectional area orfootprint of the GSAs to allow blood to flow in line with normalfunctioning of the heart. A tri-lobed GSA, for example, is shown in FIG.29, in top view. As shown, the main shaft 1420 (of a septum puncturedevice 1400) extends axially between a first lobe GSA 1450A, a secondlobe GSA 1450B, and a third lobe GSA 1450C, with the first lobe GSA1450A defining a pathway through which a side catheter or side catheterguide can be routed.

In some embodiments, a septum puncture device can include GSAs withmultiple lobes in which at least two of the multiple lobes aredissimilar in size or shape, as illustrated in FIG. 30, in top view. Asshown in FIG. 30, the septum puncture device 1500 includes a first lobeGSA 1550A, a second lobe GSA 1550B, and a third lobe GSA 1550C, in whichthe first lobe GSA 1550A has a size different from a size of the secondlobe GSA 1550B.

In some embodiments, to further reduce the risk of blood flow occlusion,one or more GSAs can have a particular aspect ratio. For example, aportion of a septum puncture device 1600 is in FIG. 31, in side view, inwhich a first GSA 1650A and a second GSA 1650A have a collective heightof L1. Minimizing L1, in some instances, can help limit any risk ofblood flow occlusion. In this implementation, for example, L1 is lessthan a collective width or collective diameter of the first GSA 1650Aand the second GSA 1650B, as illustrated by L2.

In some embodiments, a septum puncture device can include interlockedGSAs. For example, as shown in FIG. 32, in side view, a first tri-lobedGSA 1750A and a second tri-lobed GSA 1750B of a septum puncture device1700 are rotatably offset about the main shaft 1750 and relative to eachother, and then brought into engagement and interlocked. In someimplementations, for example, the first tri-lobed GSA 1750A can berotated about 60 degrees about the main shaft 1750 and relative to thesecond tri-lobed GSA 1750B, and then interlocked. In otherimplementations, other degrees of rotations can be used.

In some embodiments, a septum puncture device can include an asymmetricGSA. For example, as shown in FIG. 33, in side view and top view, aseptum puncture device 1800 includes an asymmetric GSA 1850circumferentially disposed about a main shaft 1820.

In some embodiments, a septum puncture device can include two sidecatheters (or side catheter guides) extending and disposed between GSAsin different or opposite directions such that the main shaft can berotated to selectively align one, but not the other, side catheter (orside catheter guide) with a target location to be penetrated. Forexample, as shown in FIG. 34, in side view, a septum puncture device1900 includes a first GSA 1950A and a second GSA 1950B, collectivelydefining two pathways therebetween in an opposite directions. In thismanner, as shown, a first side catheter 1960A can be disposed in orrouted through the first pathway defined between the first GSA 1950A andthe second GSA 1950B, and a second side catheter 1960B can be disposedin or routed through the second pathway defined between the first GSA1950A and the second GSA 1950B. In use, for example, an operator canrotate the main shaft 1920 about its central axis to selectively alignonly one (at a time) of the first GSA 1950A or the second GSA 1950B witha target location (e.g., the septum, or FO).

In some embodiments, a septum puncture device can include a guidecoupler that is configured to couple a side catheter guide or sidecatheter (without the side catheter guide in some embodiments) to a mainshaft such that the guide coupler is slidable with the side catheter andrelative to the main shaft. An exemplary embodiment is shown in FIGS.35A-35D, in which a septum puncture device 2000 in shown in variousstages of a deployment sequence.

Similar to or the same as described with respect to other septumpuncture devices described herein, the septum puncture device 2000 canbe used to access a left side of the heart (e.g., left atrium) from theright side of the heart (e.g., right atrium) and to deliver a guidewireto the left side of the heart. The septum puncture device 2000 can beconstructed the same as or similar to, and can function the same as orsimilar to, any of the septum puncture device described herein. Thus,portions of the septum puncture device 2000 are not described in furtherdetail herein.

In this embodiment, the septum puncture device 2000 includes a body (notshown) slidably disposed about a side catheter guide 2030 and atelescopable main shaft 2020. The side catheter guide 2030 is coupled tothe main shaft 2020 via a guide coupler 2040, as shown in FIG. 35A. Theguide coupler 2040 is slidable relative to the main shaft 2020. Disposeddistal to the body (not shown) is a pusher 2096 slidably andcircumferentially disposed about the main shaft 2020. The main shaft2020 includes a GSA 2050 disposed distal to the guide coupler 2040. Thepusher 2096 is configured to be advanced relative to the main shaft 2020and into contact with the guide coupler 2040 to push/advance the guidecoupler 2040, and attached side catheter guide 2030, towards and intocontact with the GSA 2050, such that a distal end portion of the sidecatheter guide 2030 laterally deflects about the guide coupler 2040 andthe GSA 2050, similar to as described herein in other embodiments, andas shown across FIGS. 35A-35D.

In some procedures involving a septum puncture device it may bedesirable to sense various parameters, such as pressure, flow,temperature, oxygen, etc., at or near the septum puncture device, e.g.,within a heart of a patient. In a procedure to access the LA of theheart, for example, it may be desirable to determine a pressure withinthe heart, such as within the RA or the LA. Accordingly, in any of theembodiments described herein, a sensor can be coupled to the septumpuncture device. In some implementations, for example, a septum puncturedevice can include an intracardiac echo (“ICE”) sensor configured toenhance visualization capabilities for the operator during theprocedure. An illustrative example is shown in FIG. 36. FIG. 36illustrates a portion of a septum puncture device 2100 having an ICEsensor disposed within a catheter C. The catheter can be representativeof a main shaft, a side catheter guide, a side catheter, or a septumpenetrator. In this manner, the ICE sensor can provide visualizationfrom various orientations and positions within the patient, dependingon, for example, a location within the septum puncture device withinwhich the ICE is disposed.

In some embodiments, in addition to or instead of the ICE sensor orother suitable sensors, a septum puncture device can include a camera.An illustrative example is shown in FIG. 37. FIG. 37 illustrates aportion of a septum puncture device 2200 having a camera 2295 disposedwithin a GSA 2250. The camera 2295 can in some implementations beconfigured to communicate wirelessly, while in other implementations thecamera 2295 can have a physical connection (e.g., wires, fiber optics,etc.) extending proximally from the camera 2295 through the main shaft2220 of the septum puncture device 2200 and out of the patient. Thecamera 2295 can be disposed in various positions within the GSA 2250,such as, for example, in contact with and coupled to an internal wall ofthe GSA 2250, or attached to a catheter disposed within the GSA 2250 (asdescribed herein with respect to various embodiments). With the camera2295 disposed within the GSA 2250, the camera 2295 can provide directvisualization of the procedure, e.g., of the septum or FO before,during, or after puncture.

In some procedures involving a septum puncture device it may bedesirable to flush an area adjacent to a septum penetrator, sidecatheter, or end effector, e.g., prior to, during, or after puncturing.To this end, any of the septum puncture devices described herein couldinclude a flusher (not shown) having an outlet near the septumpenetrator, side catheter, or end effector, and being configured toflush (e.g., with saline) an area at or adjacent to its location before,during, or after puncturing. The septum puncture device can also includea pressure transducer configured to measure pressure, e.g., within theRA or LA, before or after puncturing, e.g., to verify a successfulpuncture.

Referring now to FIGS. 38 and 39, an exemplary septum puncture device(also referred to herein as “device”) 2300 is depicted. In contrast tomany of the embodiments described above, rather than having a body thatcontains a main shaft and a side catheter side-by-side, this embodiment,the includes a cannula 2306 with a central lumen, and a stylus) 2310disposed in the lumen of cannula 2306. Cannula 2306 extends from adistal end 2302 to a proximal end 2304. Cannula 2306 has an elongatehollow tubular shape having a lumen running throughout. Cannula 2306includes an opening at its distal end 2302 and at least one elongatewindow 2308 adjacent to its distal end 2302, wherein both the openingand the at least one window 2308 are fluidly connected to the lumen ofcannula 2306. Cannula 2306 can have any suitable dimensions. Forexample, cannula 2306 can have an outer diameter of between about 14 and22 French (about 5 mm to 7 mm). In some implementations, cannula 2306can have one or more surface coatings. Suitable surface coatings canreduce friction or irritation, and can include anticoagulants such asheparin, ethylenediamine tetraacetic acid (EDTA), oxalate, or the like.

Device 2300 further includes an elongate, flexible, tubular stylus 2310sized to fit within the lumen of cannula 2306. Stylus 2310 correspondsfunctionally to the combination of the side catheter guide and sidecatheter in the embodiments described above. In some implementations,stylus 2310 has an articulated construction, such as in FIGS. 40A and40B. The articulation can extend for the entire length of stylus 2310,or only for a section of stylus 2310. In some implementations, stylus2310 is articulated for a length of between about 2 cm to 4 cm fromdistal end 2302. Stylus 2310 includes a first lumen sized to fit ahollow needle 2312, which corresponds to the septum penetrator in theembodiments described above. Hollow needle 2312 also has a guidewirelumen (corresponding to the guide wire coupler in the embodimentsdescribed above) sized to fit any suitable guidewire 2314, such as, forexample, a 0.035″ guidewire. In some implementations, stylus 2310includes one or more additional lumen, each additional lumen sized tofit a cable 2316.

Device 2300 further includes handle 2318 at its proximal end 2304 (seee.g., FIG. 41). Handle 2318 includes an extension knob 2320 and at leastone angulation screw 2322. Extension knob 2320 is connected to theproximal end of stylus 2310 and is actuatable to extend and retractstylus 2310 within cannula 2306. Each of the at least one angulationscrew is connected to the proximal end of a cable 2316 and is actuatableto extend and retract a connected cable 2316 within stylus 2310. In someimplementations, handle 2318 further includes one or more actuatableknobs or screws connectable to needle 2312 and guidewire 2314, such thatextension and retraction of needle 2312 and guidewire 2314 within stylus2310 may be achieved with precision.

Referring now to FIGS. 42A-42D, a device 2300 is shown in several stagesof stylus 2320 deployment. In FIG. 42A, stylus 2320 lies flush withincannula 2316 and does not protrude out of window 2318. In thisconfiguration (a delivery configuration), cannula 2316 may bemanipulated to a desired location without being impeded by stylus 2320.For example device 2300 can be delivered to the desired location over afirst, deliver guidewire (not shown, disposed in the guidewire lumen ofhollow needle 2322. After delivery to the desired location, the deliveryguidewire can be withdrawn from device 2300, and a second guidewire canbe disposed through device 2300 and the guidewire lumen of hollow needle2322.

In FIG. 42B through FIG. 24D, a cable 2326 is retracted within stylus2320, such as by way of a connected angulation screw 2332 on handle2328. Retracting a cable 3226 causes stylus 20 to angulate out of window2318 in the direction of the retracted cable 2326, towards a deployedconfiguration. For example, a stylus 2320 having two or more cables 2326can have its distal tip angulated in the direction of any of the cables2326 by retracting one or more cable 2326. The degree of angulation canbe varied between about 0 degrees and 90 degrees relative to the axis ofthe cannula 2316 by adjusting the amount of retraction of a cable 2326at a connected angulation screw 2332. In various implementations, stylus2320 can be repositioned within cannula 2316 by adjusting extension knob2330, such as in FIG. 42D. The combination of angulation control andpositional control of stylus 2320 relative to cannula 2316 enablesdevice 2300 to accurately aim needle 2322 towards the FO. In certainimplementations, device 2300 can be aimed at a specific location of theFO. The FO can be divided into quadrants, wherein a puncture in eachquadrant is advantageous for a specific procedure. For example, device2300 can be aimed to puncture slightly superior, posterior, and 3.5cm-4.5 cm above the mitral valve for typical MitraClip devices, and isfurther configured to puncture posterior and slightly inferior withinthe FO for typical left atrial appendage occlusion devices.

In various implementations, device 2300 can further comprise one or moremodifications to enhance its performance. For example, in someembodiments device 2300 can include one or more additional instrumentspositioned within a lumen of stylus 2320, such as an endoscope assembly,an ultrasound transducer, a temperature sensor, an oxygen probe, a flowsensor, a cauterizer, and the like. In another example, device 2310 cancomprise one or more radiopaque or echo-bright markers positioned oncannula 2316, stylus 2320, or both. The markers enable the position ofdevice 2310 to be monitored via fluoroscopy or echocardiography, and canbe placed at or near structures of interest, including but not limitedto the distal tips of cannula 2316 and stylus 2320 and the at least onewindow 2318.

In some embodiments, device 2300 can include an atraumatic support 2334as shown in FIGS. 43A and 43B. Atraumatic support 2334 has an elongatetubular shape and can fit within the first lumen of stylus 2320 aroundneedle 2322. Atraumatic support 2334 further comprises a blunt tip atits distal end. In some implementations the blunt tip includes aninflatable balloon. In still another implementation, the blunt tip is aflattened end-effector. In still yet another implementation, the blunttip is a ring-like end-effector. The blunt tip of atraumatic support2334 provides the distal end of stylus 2320 with a greater surface areato minimize injury and increase stability by providing uniform pressurewhen placed against a tissue surface, such as the FO. In FIG. 44, device2310 is depicted having atraumatic support 2336 with a bell-tipconfigured to be collapsible and withdrawable into a sheath 2338attached to the distal end of stylus 2320. Similar to atraumatic support2334, atraumatic support 2336 is generally configured to increase thesurface area of stylus 2320 that is in contact with the FO tissue (priorto puncturing the FO) to decrease the pressure on the tissue and toreduce or prevent the likelihood of premature puncture or damage. Acollapsible design enables device 2310 to support a wide bell-tip, suchas width of between about 8 mm and 15 mm, within the confines of cannula2316. Referring now to FIGS. 45A-45D, the geometry of atraumatic support2336 is shown in detail. Atraumatic support 2336 comprises a bell-tip atits distal end having a plurality of undulating folds. Withdrawingatraumatic support 2336 into sheath 2338 causes the bell-tip to bunchtogether in a controlled manner to fit within sheath 2338 whilemaintaining a space for the passage of needle 2322. Needle 2322 isthereby capable of being extended and retracted past the bell-tip ofatraumatic support 2336 regardless of whether the bell-tip is in acollapsed or an open configuration.

In some implementations, device 2300 can include a stiffening elementconfigured to modify the rigidity of a section of device 2323.Increasing the stiffness of a section of device 2300, such as a sectionof cannula 2316 comprising at least one window 2318, provides device2300 with a stable backbone against which an extended stylus 2320 andneedle 2322 can push against to penetrate a tissue.

Referring now to FIGS. 46A and 46B, device 2300 is depicted with astiffening element comprising spine 2340 and cable 2342. Spine 2340 ispositioned within a second lumen of cannula 2316 and extends to at leastthe location of the at least one window 2318. Spine 2340 is constructedsuch that it is flexible when loose and stiff when compacted. Forexample, in some implementations, spine 2340 is an elongate tubularmember constructed from a compressible polymer. In otherimplementations, spine 2340 is made from a long chain of interlockingsegments or from a series of hollow tubules loosely positioned next toone another, constructed, for example, from either a plastic or a metal.Cable 2342 runs through the entire length of spine 2340 and comprises atip at its distal end that is wider than spine 2340. Retracting cable2342 presses its tip against the distal end of spine 2340, therebycompacting the entire length of spine 2340 and stiffening spine 2340 andthe length of cannula 2316 that spine 2340 resides in. Extending cable2342 relieves the pressure that its tip exerts on the distal end ofspine 2340, which relaxes spine 2340 and the length of cannula 2316 thatspine 2340 resides in.

Referring now to FIGS. 47A-47D, an exemplary segmented septum puncturedevice 2400 is depicted. Device 2400 comprises a plurality ofinterlocking segments 2456 between a distal end 2452 and a proximal end2454. Interlocking segments 2456 can have any suitable construction toform an elongate, flexible member. For example, in some implementations,tach interlocking segment 2456 comprises a first end having a smallhollow spherical shape and a second end having a large hollow sphericalshape, such that the first end of one interlocking segment 2456 fitsflush within the second end of another interlocking segment 2456 to forma ball joint. A plurality of interlocking segments 2456 connected inthis manner thereby forms an elongate, articulating series of balljoints. In other implementations, interlocking segments 2456 can form agooseneck member, a snake chain member, and the like. Device 2400further comprises at least a first cable 2458 a, a second cable 2458 b,and a third cable 2458 c running throughout its entire length, eachcable 2458 a, 2458 b, and 2458 c being arranged equidistantly from eachother in a radial pattern. Each cable 2458 a, 2458 b, and 2458 c isattached to the distal-most interlocking segment 2456, such thatretracting any one or two of cable 2458 a, 2458 b, or 2458 c causesdistal end 2452 of device 50 to curl in the direction of the retractedcables. Retracting all of the cables 2458 a, 2458 b, and 2458 c with thesame amount of force causes device 2450 to stiffen and retain itsinstant shape.

Referring now to FIGS. 48A-48D, two exemplary configurations of device2450 are shown. In FIGS. 48A-48D, device 2450 fits within the lumen of acannula 2462 and comprises a needle 2460 running throughout its hollowinterior. In FIGS. 48C and 48D, device 2450 fits within a first lumen ofcannula 2462 and needle 2460 fits within a second lumen of cannula 2462.In this configuration, the hollow interior of device 2450 can be used tohouse an additional instrument, such as an endoscope assembly, anultrasound transducer, any number of sensor probes (includingtemperature probes, oxygen sensors, flow sensors), or the like.

Referring now to FIGS. 49-52, an exemplary septum puncture device 2500is depicted. Similar to other septum puncture devices described herein,device 2500 comprises a cannula 2506 (corresponding to the main body ofembodiments described above) extending from a proximal end 2502 to adistal end 2504. Cannula 2506 has an elongate hollow tubular shapehaving a lumen running between an opening at its proximal end 2502 andits distal end 2504. In some embodiments, cannula 2506 can be describedas having two segments, a proximal cannula 206 a and a distal cannula2506 b. Near distal end 2504 and positioned between proximal cannula2506 a and distal cannula 2506 b, device 2500 comprises a balloon 2508(corresponding to the GSA in embodiments described above) that isinflatable from a relaxed state to an expanded state. Balloon 2508 iselastic and can be waterproof. Balloon 2508 may be inflatable to apressure of between about 2 and 20 atmospheres using any suitable fluid,including liquids (such as saline) and gases (such as air). Higherinflation pressures generally increase the rigidity of balloon 2508 forincreased stabilization (i.e., vertical and lateral). In someembodiments, balloon 2508 can be supported by one or external arms orenveloped in a mesh for additional stabilization, such as duringinflation or tissue puncture. Balloon 2508 can be inflated to anydesired diameter. In some embodiments, the inflated diameter of balloon2508 is contextual to the anatomical space within which it ispositioned. For example, balloon 2508 can be inflated to have a diameterthat presses or does not press against the walls of a right atrium orthe inferior vena cava, for example, to provide further stability forextending stylus 2512 to puncture a FO (in some cases generally reducingthe image guidance requirements).

An exemplary internal arrangement of device 2500 is shown in FIG. 50 ina cross-sectional view of device 2500 taken proximal to balloon 2508.The lumen of cannula 2506 is sized to fit an elongate tubular sheath2510 (corresponding to the side catheter guide of embodiments describedabove), which has a lumen sized to fit an elongate tubular stylus 2512(corresponding to the side catheter of embodiments described above),which in turn has a lumen sized to fit hollow needle 2514 (correspondingto the septum penetrator of embodiments described above), which in turnhas a lumen sized to fit a guidewire 2516 (e.g., the guidewire to bedelivered through the septum, corresponding to guidewire GW2 inembodiments described above). Cannula 2506 further comprises a secondguidewire lumen 2517 sized to fit a second guidewire GW1 (e.g. theguidewire over which device 2500 is to be delivered to the desiredlocation, corresponding to guidewire GW1 in embodiments describedabove). Guidewire 2516 can be any suitable guidewire, such as a 0.035″guidewire, a 0.025″ guidewire, a curlycue wire (e.g., a Baylis leftatrial wire), and the like. Inflation tube 209 is provided within thelumen of cannula 2506, wherein inflation tube 2509 has an internal lumenfluidly connected to balloon 2508 for inflation and deflation. In someembodiments, cannula 2506 can include one or more stiffening rods 2518having a selected length to provide device 2500 with greater stiffnessin desired sections.

A distal tip of sheath 2510 is secured to an exterior surface of balloon2508 by balloon grommet 2507. In this configuration, balloon 2508 can beinflated and deflated without leaking out of balloon grommet 2507 orsheath 2510, and sheath 5210 can provide access to the exterior ofballoon 2508. Grommet 2507 can include a smooth interior surface (orother surface treatment) to reduce friction between stylus 2512 andgrommet 2507, such as when inflating or deflating balloon 2508 or whenadvancing or retracting stylus 2512 through sheath 2510. Grommet 2507may be constructed from any suitable material, including a plastic, ametal, a composite, a ceramic, and the like. Grommet 2507 can be furtherconfigured to have a particular shape or edging, such that the interiorsurface has a bevel or chamfer. In one embodiment, grommet 2507 ispositioned at a widest radial point or circumference on balloon 208,although grommet 2507 is not limited by placement in other locations.

In some implementations, stylus 2512 has an atraumatic end effector 2511positioned at a distal tip (e.g., similar to or the same as depicted inFIG. 59B), wherein end effector 2511 has a disc-shape configured to tenta tissue (such as the FO) and apply pressure without inadvertentpuncturing. End effector 2511 can have a bell-tip configured to becollapsible and withdrawable into sheath 2510. A collapsible designenables device 2500 to support a wide bell-tip, such as width of betweenabout 8 mm and 15 mm, within sheath 2510. End effector 2511 can comprisea bell-tip having a plurality of undulating folds. Withdrawing endeffector 2511 into sheath 2510 causes the bell-tip to bunch together ina controlled manner to fit within sheath 2510 while maintaining a spacefor the passage of needle 2514. Needle 2514 is thereby capable of beingextended and retracted past the tip of end effector 2511 regardless ofwhether the tip is in a collapsed or an open configuration. In someembodiments, the lumen of stylus 1510 can accept a radiofrequency probehaving a rounded metal tip, wherein the metal tip can be electrifiedwith a current (e.g., radio ablation) to puncture tissue in lieu of aneedle.

Device 2500 is configured to increase lateral stability of needle 214while puncturing a tissue, such as the FO. Balloon 2508 has an expandedstate (FIG. 49) and a relaxed state with a thin profile (FIG. 52). Therelaxed state defines a delivery configuration for device 2500 andpermits device 2500 to be guided into the right atrium of a patient'sheart such that distal end 2504 of device 2500 can be positioned withina subject's superior vena cava. In some embodiments, balloon 2508 in arelaxed state can be folded over end effector 2511, stylus 2512, andsheath 2510, wherein the folded configuration (or deliveryconfiguration) is maintained during insertion and advancement of device2500 to a right atrium (similar to an intraortic balloon pump). Thus,device 2500 does not generally require a “sheath” catheter to bepositioned over (i.e., cover) the assembly of a folded balloon 2508, endeffector 2511, stylus 2512, and sheath 2510 during insertion orwithdrawal. In some implementations, device 2500 can be provided with acasing or sleeve that slides over balloon 2508 in a relaxed state. Inthe expanded state, balloon 2508 is configured to be sufficiently rigidto enhance stability (e.g., lateral stability). In some embodiments,balloon 2508 is configured to selectively press against the wall of aright atrium adjacent to the FO to further enhance stability (e.g.,lateral stability). Device 2500 thereby provides stability in the areaimmediately behind stylus 2512 by expanding to provide a largerclearance for FO access.

In some embodiments, balloon 2508 is configured to increase thestability and precision (i.e., steerability of stylus 2512) ofpuncturing tissue. For example, grommet 2507 can be placed at a point onballoon 2508, as described above, such that stylus 2512 protrudesthrough balloon 2508 by way of sheath 2510 at an angle with respect to along axis of cannula 206 when balloon 2508 is in an expanded state.Thus, balloon 2508 functions similar to the GSA in embodiments describedabove. In some embodiments, the angle is between about 60 and 180degrees. In some embodiments, the angle is between about 60 and 140degrees. In some embodiments, the angle is between about 60 and 100degrees. In some embodiments, the angle is between about 80 and 120degrees. In some embodiments, the angle is approximately 90 degrees. Insome embodiments, the angle is approximately 80 degrees (e.g., see FIG.59A). In some embodiments, the angle is approximately 110 degrees. Insome embodiments, stylus 2512 can protrude approximately 3-4 cm fromballoon 2508, such that the protruding portion of stylus 2512 isgenerally straight.

Balloon 2508 can be further configured to affect the angle of stylus2512 when inflated. For example, balloon 2508 may have a generallyspherical-like shape, while in other implementations balloon 2508 has anelliptical-like shape. Still further, balloon 2508 may be generallysymmetric or asymmetric (see FIG. 53A). For example, an asymmetricballoon 2508 may have an inflated radius that is larger at grommet 2507than at a portion of balloon 2508 opposite grommet 2507. In anotherexample, an asymmetric balloon 2508 may have an inflated radius that isdifferent at grommet 2507 than at portions of balloon 2508circumferentially adjacent to grommet 2507. From a cross-sectional view,cannula 2506 would thereby be non-centric with an inflated balloon 2508.Thus, grommet 2507 can be positioned at a point on balloon 2508 (havingan inflated radius) that provides a preferred angle of stylus 2512 whenballoon 2508 is in an expanded state to increase stability andsteerability of stylus 2512.

In some implementations, balloon 2508 can be shaped to allow blood flowaround balloon 2508. For example, balloon 2508 may have a plurality oflobes, such as longitudinally-oriented (or axially-oriented) lobes (seeFIG. 53B). In an expanded state, lobes on balloon 2508 provide lateralstability by positioning stylus 2512 at a preferred angle, while avaried inflated radius of balloon 2508 permits blood to flow aroundportions of balloon 2508 (e.g., if balloon 2508 were to become wedged ineither the superior or inferior vena cava). Furthermore, lobes onballoon 2508 may have lateral aspects to further increase lateralstability of stylus 2512. For example, the plurality of lobes may formspiral-like or helical shapes or patterns.

In some implementations, balloon 2508 may be positioned adjacent tocannula 2506. As shown in FIG. 53C, sheath 2510 can be cradled within agroove in cannula 2506 with balloon 208 folded around sheath 210.Inflating balloon 2508 pushes sheath 2510 away from cannula 2506,thereby positioning stylus 2512 within at a desired angle. In someimplementations, the angle can be adjusted by varying the amount ofinflation in balloon 2508.

In some implementations, balloon 2508 may be shaped to have a concave orconvex surface. For example, FIGS. 54A-54C depict a device 2500 having aballoon 2508 with a concave proximal surface. Sheath 2510 can beattached to the concave proximal surface and curve accordingly, therebybeing configured to direct stylus 2512 outward in a lateral direction.In some implementations, sheath 2510 can be external or partiallyexternal to balloon 2508. For example, FIG. 55 depicts a cross-sectionalview of a sheath 2510 that is partially embedded within an exteriorsurface of balloon 2508. It should be understood that sheath 2510 canhave any desired cross-sectional shape, including but not limited to theoval-like and arcuate cross-sections depicted in FIG. 55.

In various implementations, device 2500 can further comprise one or moremodifications to enhance its performance. For example, device 2500 canbe modified to include additional sheaths 2510, styluses 2512, needles2514, and guidewires 2516, similar to the embodiments illustrated inFIGS. 19-23 and described above. As shown in FIG. 56, the additionalsheaths 2510, styluses 2512, needles 2514, and guidewires 2516 can besecured to balloon 2508 to provide separate puncture sites. In this way,stylus 2512 can be used to allow separate punctures to perform differentprocedures or perform different steps of a procedure, such a firstneedle 2514 for a first procedure or step and a second needle 2514 for asecond procedure or step, etc. Each needle 2514 can be positionedrelative to each other on the FO (e.g., by positioning stylus 2512within the right atrium, rotating stylus 2512, and adjusting the angleof stylus 2512) to preferably position each of the needles 2514 on theFO for each respective procedure or step of the procedure that they arebeing used. Thus, device 2500 can be configured to have multipleextendable elements in close proximity to allow simultaneous punctures.

In another example, device 2500 can comprise one or more corrugations orradiopaque, echo-bright, or sonically opaque markers. The markers enablethe position of device 2500 to be monitored via fluoroscopy orechocardiography, and can be placed at or near structures of interest,including but not limited to at least a portion of cannula 2506, stylus2512, end effector 2511, balloon 2508, or the like.

The various components of the embodiments described herein can beconstructed using any suitable method. The method of making may varydepending on the materials used. For example, components substantiallycomprising a metal may be milled from a larger block of metal or may becast from molten metal. Likewise, components substantially comprising aplastic or polymer may be milled from a larger block, cast, or injectionmolded. In some embodiments, the devices may be made using 3-dimensional(“3D”) printing or other additive manufacturing techniques. Further, itshould be understood that any descriptions applicable to one embodimentof the present invention are equally applicable to all embodimentsdescribed elsewhere herein.

The septum puncture devices described herein can be used in conjunctionwith any suitable handle adapted to the components of the devices.Referring now to FIG. 57, an exemplary handle assembly 2680 is depicted.Handle assembly 2600 comprises main shaft handle 2602 engaged to a sidecatheter handle 304 by a side catheter deflection knob 2606. Knob 2606can be tightened to secure handle 2604 to handle 2602 and loosened topermit handle 2604 to be actuated relative to handle 2602. Handleassembly 2680 further comprises a plurality of lumens connected toopenings, the lumens and openings sized to receive guidewires andneedles. Handle 2602 comprises a lumen and opening connected to aballoon inflation syringe 2608. A valve or stopcock 2610 is provided atthe engagement between handle 2602 and syringe 2608. Handle assembly2680 further comprises a needle tube handle 2612 and a needle safety tab2614.

While handle assembly 2680 is connectable to any septum puncture devicedescribed herein, it is now described in relation to device 2500 byexample. Handle 2602 is connectable to a proximal end of a cannula of aseptum puncture device, such as cannula 2506, to manipulate, rotate,advance, and withdraw the cannula. Handle 2604 is connectable to aproximal end of a stylus of a septum puncture device, such as stylus2512, to manipulate, rotate, advance, and withdraw the stylus. A venousguidewire 2516 inserted into the distal opening of device 2500 isconfigured to exit handle assembly 2680 through a side opening on handle2602. Syringe 2608 is fluidly connected to inflation lumen 2509 toinflate and deflate balloon 2508, wherein stopcock 2610 can be actuatedto maintain or release the inflated state of balloon 2508. Needle 2514is connected at a proximal end to handle 2612, wherein needle safety tab2614 can be clipped onto the proximal end of needle 2514 between handle2604 and handle 2612 to prevent inadvertent extension of needle 2514. Anatrial guidewire 2516 residing within needle 2514 can extend proximallyfrom handle 2612. In various embodiments, handle assembly 2680 furthercomprises one or more actuatable knobs or screws connectable to thecannula, styluses, needles, and guidewires, such that extension andretraction of the components may be achieved with precision. In someembodiments, handle assembly 2600 can include components configured tofurther steer the components, such as pull cables.

Referring now to FIG. 58 and FIGS. 59A-59D, the operation of device 2500using handle assembly 2680 is described. In FIG. 59A, balloon 2508 isinflated to an expanded state using syringe 2608 and is maintained in anexpanded state by closing stopcock 2610. The inflation of balloon 2508angles sheath 2510 away from cannula 2506, such as by an angle of 80degrees relative to a long axis of cannula 2506. In FIG. 59B, knob 2606is loosened to advance handle 604 towards handle 2602 and extend stylus2512 out of sheath 2510, exposing end effector 2511. Stylus 2512 can beextended by any desired length, such as about 3-4 cm, and held in placeby tightening knob 2606. In FIG. 59C, device 2500 is positioned adjacentto an atrial septum such that end effector 2511 presses against andtents the FO. In FIG. 59D, needle safety tab 2614 is removed to allowhandle 2612 to be advanced toward handle 304 and extend needle 2514 outof stylus 2512 to pierce the FO. Needle 2514 can be extended by anydesired length, such as about 4-10 mm. Atrial guidewire 2516 can then beadvanced in a distal direction to pass through needle 2514, the FO, andinto the left atrium.

Another embodiment of a device 2700 is shown in FIGS. 60A to 60D. Device2700 has a plurality of slits 2775 positioned near its distal enduniformly distributed around the body, defining therebetween a pluralityof arms 2776. Compressing device 2700 on either side of the plurality ofslits 2775 expands the arms 2776 outwards, exposing stylet cathetersection 2778, which may have a rigid construction, formed by either ahard plastic or a metal, and permits at least the distal end 2771 ofcannula 2774 to advance proximally over catheter section 2778 to achieveexpansion of arms 2776. In certain embodiments, the distal end 2771 ofcannula 2774 is manipulated using one or more pull cables runningthrough the length of device 2700. For example, the one or more pullcables can be equally retracted to expand each arm 2776 uniformly and toform equally sized openings between each arm 2776. In another example,the one or more pull cables can be selectively retracted, such that pullcables subjected to more tension cause greater expansion in the arms2776 closest to those pull cables, varying the geometry of the openingbetween each arm 2776. Expanded arms 2776 provide clearance for theextension of stylet 80 out of catheter section 78, and also for theextension of hollow needle 82 out of stylet 80 and any desiredguidewires out of hollow needle 2782.

A device 2700 has a relaxed state with a thin profile (or deliveryconfiguration, shown in FIG. 60A) and an expanded state (or deployedconfiguration, shown in FIG. 60B). The relaxed state permits device 2700to be guided into the right atrium of a patient's heart such that thedistal end of device 2700 rests in the patient's super vena cava. In theexpanded state, the plurality of arms 2776 are configured to selectivelypress against the wall of the right atrium adjacent to the FO to enhancestability (e.g., lateral stability). Device 2700 thereby provides atleast two stable platforms for septum puncture using stylet 2780: theplurality of arms 2776 pressing directly against the heart tissue, andthe catheter section 2778 suspended between the plurality of arms 2776.Selective retraction of pull cables in device 2700 to non-uniformlyexpand device 2700 can be desirable in certain situations. For example,device 2770 can be expanded such that the arms 2776 adjacent to stylet2780 are greatly expanded to provide a larger clearance for FO access,while the arms 2776 behind stylet 2780 can be expanded to a lesserdegree to increase stability in the area immediately behind stylet 2780.

Referring now to FIGS. 61A-61H, further implementations of variousconfigurations of device 2700 are depicted. While exemplary devices 2700are depicted with three and six arms 2776, it should be understood thatdevice 2700 can have any suitable number of arms 2776, such as betweenabout three and ten arms. In certain embodiments, the plurality of arms2776 can each be linked by one or more bands 2786, as shown in FIGS. 61Eand 61F. By linking each arm 2776 to its adjacent arm 2776, band 2786increases the stability of device 2700 by mitigating lateral motion ofeach arm 2776 and prevents injury from excessive expansion of arms 2776.In certain embodiments, the plurality of arms 2776 can be encased incovering 2788, as shown in FIGS. 61G and 61H. Covering 2788 is elasticand can be waterproof to smoothly guide device 2700 in a relaxed stateand to provide a greater surface area in an expanded state that spreadsout pressure and decrease trauma. Covering 2788 also provides the samebenefits of band 86, in that covering 88 mitigates lateral motion andexcessive expansion of arms 76 to improve stability. In FIG. 61H, stylet2780 and needle 2782 are depicted as capable of piercing throughcovering 2788 to access and puncture the FO.

Referring now to FIGS. 62A and 62B, an exemplary implementation ofdevice 2700 is depicted having loop guide 2789. Loop guide 2789 providesadditional stability by linking an extended stylus 2780 to an expandedarm 2776. In some embodiments, loop guide 2789 is attached to the distalend of stylus 2780, such that after expanding the plurality of arms2776, stylus 2780 can be extended along an expanded arm 2776 as loopguide 2789 slides over the expanded arm 2776. In other embodiments, loopguide 2789 is welded to both the distal end of stylus 2780 and to anexpanded arm 2776, such that the expanding action of arm 2776simultaneously extends stylus 2780 and curves stylus 2780 towards a FO.

Referring now to FIGS. 63A-63C, an exemplary hinged septum puncturedevice 90 is depicted. Device 2800 has a distal end 2891, a proximal end2892, and a cannula 2894 running throughout. Device 2800 has a hingedarm 2895 near its distal end 2891, the hinged arm 2895 resting withincannula 2894 adjacent to window 2896. Hinged arm 2895 is attached to thedistal end of stylus 2898, such that rotating hinged arm 2895 out ofwindow 2896 extends stylus 2898 out of cannula 2894 to face towards aFO. While exemplary embodiments of device 2800 are shown with one andtwo points of articulation in FIGS. 63B and 63C, respectively, it shouldbe understood that hinged arm 2895 can have any suitable number ofpoints of articulation, such as between about one and ten. Hinged arm2895 can be rotated using any suitable means, including but not limitedto one or more pull cables, one or more servomotors, one or morehydraulic pistons, or the like.

Moreover, in general, devices such a catheters introduced into thevasculature of a patient carry a risk of inadvertent trauma to thepatient's vascular wall and/or associate tissues, organs, etc. A sharpedge of a device, for example, could lacerate a vascular wall. In thecontext of this disclosure, a main shaft (e.g., main shaft 120), and/ora side catheter guide (e.g., side catheter guide 130) of a septumpuncture device could exert a traumatic force against a wall of a curvedor tortuous vessel. This could be of particular concern, for example,when a relatively stiff main shaft is used (e.g., for purposes ofproviding stability between the IVC and SVC). Further, having a sidecatheter guide adjacent the main shaft may present additional similarrisks. To address such risks, any suitable portions of the septumpuncture devices described herein can have atraumatic designs. FIGS. 65Aand 65B illustrate such a septum puncture device 2900, according to anembodiment. Similar to or the same as described with respect to theseptum puncture devices described herein, the septum puncture device2900 can be used to access a left side of the heart (e.g., left atrium)from the right side of the heart (e.g., right atrium) and to deliver aguidewire to the left side of the heart. The septum puncture device 2900can be constructed the same as or similar to, and can function the sameas or similar to, any of the septum puncture devices described herein(e.g., septum puncture device 100). Thus, portions of the septumpuncture device 2900 are not described in further detail herein.

As shown in FIG. 65A, the septum puncture device 2900 includes a body2910 coupled to a main shaft 2920, a side catheter guide 2930, a sidecatheter 2960 (with an optional end effector 2962 extending therefrom),a septum penetrator 2970, and an atraumatic tip 2945. The main shaft2920 is coupled to the side catheter guide 2930 via a guide coupler2940, the side catheter guide 2930 is coupled to the side catheter 2960,and the side catheter 2960 is coupled to the septum penetrator 2970, asshown in FIG. 65A. The side catheter guide 2930 is configured to definea pathway through or across which the side catheter 2960 can travel(e.g., be advanced and/or withdrawn). Said another way, and as describedin further detail herein, the side catheter guide 2930 can bemanipulated (e.g., actuated from a delivery state to a deployed state)to guide the side catheter 2960 in a desired direction (the actuated ordeployed state of the side catheter guide 2930 is shown in FIG. 65B),e.g., towards the left atrium.

The atraumatic tip 2945 is configured to protect the patient frominadvertent trauma caused by a portion of the side catheter guide 2930,such as, for example, a distal end portion of the side catheter guide2930, which during insertion is guided into the patient's vasculature bythe main shaft 2920. The atraumatic tip 2945 can be formed of anysuitable material and can have any suitable shape. In someimplementations, the atraumatic tip 2945 can be mounted on and/orcoupled to the main shaft 2920. In some implementations, for example,the atraumatic tip 2945 be a nosecone (e.g., a blunt nosecone) mountedon and/or coupled to the main shaft 2920, with a tapered leading edgeand a radiused trailing edge (e.g., such that the atraumatic tip 2945 isvoid of sharp edges). In some implementations, the atraumatic tip 2945can be asymmetrically mounted on or coupled to the main shaft 2920 suchthat the atraumatic tip 2945 protects a distal end portion of the sidecatheter guide 2930 while limiting an overall diameter, cross-sectionalarea, and/or profile of the main shaft 2920 and side catheter guide2930.

In some implementations, the atraumatic tip 2945, the main shaft 2920,and/or the body 2910 can be monolithically formed, while in otherimplementations, the atraumatic tip 2945, the main shaft 2920, and/orthe body 2910 can be formed separately and then coupled to one another.In some such implementations, for example, the body 2910 and theatraumatic tip 2945 can be monolithically formed. Further to thisexample, the body 2910 and the atraumatic tip 2945 can define a lumenthrough which the main shaft 2920 can be slidably disposed. Further, thebody 2910 and atraumatic tip 2945 can be configured to extend distallyrelative to the main shaft 2920 as far as desired; for example, the body2910 and the atraumatic tip 2945 can have a distal end terminatingproximal to the distal end of the main shaft 2920, at the distal end ofthe main shaft 2920, or distal to the distal end of the main shaft 2920.Further, the monolithically formed body 2910 and atraumatic tip 2945 candefine a lateral opening to allow for the side catheter guide 2930 toextend and/or laterally deflect (e.g., away from the septum) and alateral opening to through which the distal end of the side catheterguide 2930, the side catheter 2960, the septum penetrator 2970, and/orthe guide wire (e.g., to be delivered to the left atrium), can extend.

In some implementations, the main shaft 2920 and the atraumatic tip 2945can be monolithically formed, and define a lumen through which the sidecatheter guide 2930 (and a guide wire, for example) can be disposed. Insome such implementations, the main shaft 2920/atraumatic tip 2945 caninclude a guide coupler coupler (not shown) configured to facilitatecoupling of the main shaft 2920/atraumatic tip 2945 to the guide coupler2940. The guide coupler coupler can be any suitable mechanism or featuresuitable to secure the guide coupler 2940 to the main shaft2920/atraumatic tip 2945. As an example, the guide coupler coupler canbe a plurality of lateral apertures, slots, or the like defined by themain shaft 2920/atraumatic tip 2945 and configured to receive a portionof the guide coupler 2940.

In some implementations, the atraumatic tip 2945 can have a distal endconfigured to be spaced distal to the guide coupler 2940, a proximal endextending towards the body 2910, and two lateral openings disposedbetween the distal end and the proximal end; one lateral openingconfigured to allow for the side catheter guide 2930 to extend and/orlaterally deflect (e.g., away from the septum) and the other lateralopening configured to provide access through which the distal end of theside catheter guide 2930, the side catheter 2960, the septum penetrator2970, and/or the guide wire (e.g., to be delivered to the left atrium),can extend.

As described in further detail herein in other embodiments, the guidecoupler 2940 can couple the side catheter guide 2930 to the main shaft2920 to minimize or prevent relative translational movement between themain shaft 2920 and the side catheter guide 2930, but to allow relativerotational movement between the main shaft 2920 and the side catheterguide 2930, as illustrated schematically in FIG. 65B. In this manner,the guide coupler 2940 can facilitate transition of the side catheterguide 2930 from a delivery configuration (e.g., parallel to orsubstantially parallel to the main shaft 2920), e.g., for insertionthrough the patient's vasculature and into the RA, to a deployedconfiguration such that a distal end of the side catheter guide 2930 isdeflected angularly and/or laterally relative to the main shaft 2920,e.g., towards the patient's left atrium (e.g., the FO of the atrialseptum).

The atraumatic tip 2945 can be configured to facilitate such transitionof the side catheter guide 2930 into its deployed configuration. In someimplementations, for example, the atraumatic tip 2945 can define one ormore apertures, lateral openings, and/or slots through which the distalend portion of the side catheter guide 2930 can angularly and/orlaterally deflect, and/or through which a portion of the side catheterguide 2930 that is proximal to the distal end portion of the sidecatheter guide 2930 can extend and/or deflect (e.g., the proximalportion being one a first side of a central axis of the shaft while thedistal portion is on a second side of the central axis opposite thefirst side of the central axis. In this manner, the side catheter guide2930 is shielded prior to deployment, and free to deflect and assume anincreased profile during deployment.

In some implementations, the entire atraumatic tip 2945 can be disposeddistal to the guide coupler 2940, while in some implementations, theatraumatic tip 2945 can extend across and proximally beyond the guidecoupler 2940.

The atraumatic tip 2945 can be of any suitable size. For example, insome implementations, the atraumatic tip 2945 can have an outer diameterof about 14F. As another example, in some implementations, theatraumatic tip 2945 can have a length in a range of about 1 mm to about150 mm. In some implementations, the atraumatic tip 2945 can have alength of about 10-30 times its diameter; such a length could be, forexample, 75 mm, 100 mm, 150 mm, or any value therebetween.

In some implementations, the atraumatic tip 2945 can include aradiopaque material and/or marker (e.g., a band and/or a groove) suchthat the atraumatic tip 2945 can be visualized when within the heartfrom outside the patient under any suitable imaging modality (e.g.,fluoroscopy, echocardiography, etc.), to facilitate an operator indeploying the side catheter guide 2930 and/or the side catheter 2960.

Further as shown in FIG. 65A, the septum puncture device 2900 includes aguide wire coupler 2922 configured to couple the main shaft 2920 to aguide wire (not shown in FIG. 65A) to facilitate delivery of the septumpuncture device 2900 into a patient (e.g., through the vasculature ofthe patient) and to the patient's heart, and a guide wire coupler 2972configured to couple a guide wire (not shown in FIG. 65A) to the septumpenetrator 2970, to facilitate delivery of that guide wire to the leftside of the heart (e.g., the left atrium).

Further as shown in FIG. 65A, the septum puncture device 2900 optionallyincludes a shaft actuator 2924 operably coupled to the main shaft 2920and configured to actuate the main shaft 2920 to advance or withdraw themain shaft 2920 relative to the body 2910. The septum puncture device2900 further includes (1) a side catheter actuator 2964 operably coupledto and configured to actuate the side catheter 2960 to advance orwithdraw the side catheter 2960, thereby transitioning the side catheter2960 between a delivery configuration and a deployed configuration (theside catheter 2960 shown in an actuated or deployed configuration inFIG. 65B), and (2) a septum penetrator actuator (or “penetratoractuator”) 2974 to actuate the septum penetrator 2970 to advance orwithdraw the septum penetrator 2970, thereby transitioning the septumpenetrator between a delivery configuration and a deployed configuration(the septum penetrator 2970 shown in an actuated or deployedconfiguration in FIG. 65B), as described in further detail herein.

Further as shown in FIG. 65A, the septum puncture device 2900 optionallyincludes an end effector 2962 coupled to and extending distally from theside catheter 2960. The end effector 2962 is configured to facilitatesubsequent puncture through a target puncture location, such as, forexample, the FO of the septum of the heart. The end effector 2962 can beconfigured, for example, to contact or tent the FO, as described infurther detail herein. Such contact or tenting of the FO can, forexample, reduce or minimize the force required to penetrate the FOand/or provide for improved force distribution to the FO. The endeffector 2962 can be configured to prevent inadvertent puncturing ofand/or damage to the FO with the end effector 2962.

Each of the main shaft 2920, the guide wire coupler 2922, the sidecatheter guide 2930, the guide coupler 140, the side catheter 2960, theseptum penetrator 2970, and the guide wire coupler 2972 are translatable(e.g., distally advanceable and/or extendable, and proximallywithdrawable and/or retractable) relative to the body 2910. The sidecatheter 2960 is translatable relative to the side catheter guide 2930,and the septum penetrator 2970 is translatable relative to the sidecatheter 2960, as described in further detail herein.

FIGS. 66A and 66B illustrate a portion of a septum puncture device 3000in a delivery configuration and a deployed configuration, respectively,according to an embodiment.

Similar to other septum puncture devices described herein, the septumpuncture device 3000 can be used to access a left side of the heart(e.g., left atrium) from the right side of the heart (e.g., rightatrium) and to deliver a guidewire to the left side of the heart. Theseptum puncture device 3000 can be constructed the same as or similarto, and can function the same as or similar to, any of the septumpuncture devices described herein. Thus, portions of the septum puncturedevice 3000 are not described in further detail herein.

In this embodiment, the septum puncture device 3000 includes a mainshaft 3020 and a side catheter guide 3030 coupled to the main shaft 3020via a guide coupler 3040, similar to as described in connection withother embodiments. The septum puncture device 3000 further includes anatraumatic tip 3045 coupled to and disposed about the main shaft 3020,and abutting a distal end portion of the side catheter guide 3030 whenthe side catheter guide 3030 is in a delivery configuration. As shown inFIG. 66A, the distal end of the side catheter guide 3030 is shielded orat least partially covered by the atraumatic tip 3045. In this manner,during insertion of the septum puncture device 3000 into the patient,with the side catheter guide 3030 in its delivery configuration, theatraumatic tip 3045 protects the patient's vasculature and associatedanatomy from inadvertent trauma from the side catheter guide 3030. Whendeployed, as illustrated in FIG. 66B, the distal end of the sidecatheter guide 3030 is angularly deflected relative to the main shaft3020, as described in other embodiments herein, such that a sidecatheter (not shown) can then be extended distally therethrough.Although in this embodiment the atraumatic tip 3045 abuts the distal endportion of the side catheter guide 3030 when the side catheter guide3030 is in the delivery configuration, in other embodiments theatraumatic tip can be axially offset from the distal end portion of theside catheter guide such that the atraumatic tip is not in contact withthe side catheter guide.

Further, in this embodiment, the atraumatic tip 3045 has an asymmetricshape such that during delivery, as shown in FIG. 66A, the atraumatictip 3045 shields the entire distal end of the side catheter guide 3030,while limiting the overall footprint of the atraumatic tip 3045. Morespecifically, in this embodiment, the atraumatic tip 3045 reduces incross-sectional area from its proximal end to its distal end.

Further, the atraumatic tip 3045 includes a radiopaque (e.g.,fluoroscopic) marker band 3046 disposed circumferentially about anexterior surface of the atraumatic tip 3045. The atraumatic tip 3045defines a grove on which the radiopaque marker band 3046 is disposedsuch that the band 3046 does not increase the overall profile,cross-sectional area, and/or diameter of the remaining portion of theatraumatic tip 3045.

In some embodiments, an atraumatic tip can define or include a slot orrecess through which a side catheter guide can deflect. FIG. 67illustrates a portion of a septum puncture device 3100 in a deliveryconfiguration, according to such an embodiment.

Similar to other septum puncture devices described herein, the septumpuncture device 3100 can be used to access a left side of the heart(e.g., left atrium) from the right side of the heart (e.g., rightatrium) and to deliver a guidewire to the left side of the heart. Theseptum puncture device 3100 can be constructed the same as or similarto, and can function the same as or similar to, any of the septumpuncture devices described herein. Thus, portions of the septum puncturedevice 3100 are not described in further detail herein.

In this embodiment, the septum puncture device 3100 includes a mainshaft 3120 and a side catheter guide 3130 coupled to the main shaft 3120via a guide coupler 3140 and extending distally from a body 3110,similar to as described in connection with other embodiments. The septumpuncture device 3100 further includes an atraumatic tip 3145 coupled toand disposed about the main shaft 3120, and abutting a distal endportion of the side catheter guide 3130 when the side catheter guide3130 is in a delivery configuration. Although in this embodiment theatraumatic tip 3145 abuts the distal end portion of the side catheterguide 3130 when the side catheter guide 3130 is in the deliveryconfiguration, in other embodiments the atraumatic tip can be axiallyoffset from the distal end portion of the side catheter guide such thatthe atraumatic tip is not in contact with the side catheter guide.

The atraumatic tip 3145 can be constructed the same as or similar to,and can function the same as or similar to, the atraumatic tip 3045,except the atraumatic tip 3145, as shown, includes a slot at itsproximal end through which a distal end of the side catheter guide 3130is disposed during delivery, and through and/or beyond which the distalend of the side catheter guide 3130 can extend when deployed.

In some embodiments, an atraumatic tip can extend distally from alocation proximal to the guide coupler, across the guide coupler, anddistal to the distal end of the side catheter guide, and can define orinclude one or more slots or recesses through which the side catheterguide can be deployed and/or deflected. FIGS. 68A and 68B illustrate aportion of a septum puncture device 3200 in a delivery configuration anda deployed configuration, respectively, according to such an embodiment.

Similar to other septum puncture devices described herein, the septumpuncture device 3200 can be used to access a left side of the heart(e.g., left atrium) from the right side of the heart (e.g., rightatrium) and to deliver a guidewire to the left side of the heart. Theseptum puncture device 3200 can be constructed the same as or similarto, and can function the same as or similar to, any of the septumpuncture devices described herein. Thus, portions of the septum puncturedevice 3200 are not described in further detail herein.

In this embodiment, the septum puncture device 3200 includes a mainshaft 3220 and a side catheter guide 3230 coupled to the main shaft 3220via a guide coupler 3240. The septum puncture device 3200 furtherincludes an atraumatic tip 3245 coupled to and disposed about the mainshaft 3220, and the side catheter guide 3230 when the side catheterguide 3230 is in its delivery configuration (FIG. 68A). As shown best inFIG. 68B, the atraumatic tip 3245 defines a first slot 3246A and asecond slot 3256B (collectively referred to herein as “the slots 3246”).During delivery, the side catheter guide 3230 remains within the profiledefined by the atraumatic tip 3245, such that the side catheter guide3230 does not extend through and/or beyond the slots 3246, as shown inFIG. 68A. When deployed, as shown in FIG. 68B, the side catheter guide3230 angularly deflects such that a distal end portion of the sidecatheter guide 3230 points in first direction (e.g., towards a septum),and a portion of the side catheter guide 3230 proximal the distal endportion and opposite a central axis of the main shaft 3220 when comparedto the distal end portion, angularly and laterally deflects in a seconddirection different from the first direction. In this manner, theatraumatic tip 3245 covers and/or envelops the side catheter guide 3230to shield the side catheter guide 3230 from inadvertent contact withand/or trauma to surrounding anatomy. Also, as shown, a distal end ofthe atraumatic tip 3245 is tapered (e.g., similar to a bullet nose ornose cone) so as to be atraumatic.

In various embodiments described herein, during deployment, a distal endportion of the side catheter guide laterally deflects relative to acentral axis of the main shaft, such that the distal end of the sidecatheter guide is disposed laterally beyond an exterior surface of themain shaft (e.g., towards a septum). In some instances, it is desirableto minimize and/or avoid such lateral deflection, such that duringdeployment, the distal end of the side catheter guide angularly deflectssuch that the distal end of the side catheter guide does not extendbeyond an exterior surface of the main shaft when viewed in side view,and/or does not extend beyond an exterior surface of the atraumatic tipwhen viewed in side view (e.g., in applicable embodiments in which theseptum puncture device includes an atraumatic tip).

FIGS. 69A and 69B illustrate a portion of a septum puncture device 3300in a delivery configuration and a deployed configuration, respectively,according to such an embodiment. Similar to other septum puncturedevices described herein, the septum puncture device 3300 can be used toaccess a left side of the heart (e.g., left atrium) from the right sideof the heart (e.g., right atrium) and to deliver a guidewire to the leftside of the heart. The septum puncture device 3300 can be constructedthe same as or similar to, and can function the same as or similar to,any of the septum puncture devices described herein. Thus, portions ofthe septum puncture device 3300 are not described in further detailherein.

In this embodiment, the septum puncture device 3300 includes a mainshaft 3320 and a side catheter guide 3330 coupled to the main shaft 3320via a guide coupler 3340. The septum puncture device 3300 furtherincludes an atraumatic tip 3345 coupled to and disposed about the mainshaft 3320, and the side catheter guide 3330 when the side catheterguide 3330 is in its delivery configuration (FIG. 69A). As shown best inFIG. 69B, the atraumatic tip 3345 defines a first slot 3346A and asecond slot 3356B (collectively referred to herein as “the slots 3346”).

In this embodiment, the guide coupler 3340 is disposed close to a distalend of the side catheter guide 3330 such that when the side catheterguide 3330 is deployed, its distal end deflects angularly, without anysubstantial lateral deflection, such that the distal end of the sidecatheter guide 3330 when deployed does not increase the collectivecross-sectional area of the main shaft 3320 and the atraumatic tip 3345.Said another way, the distal end of the side catheter guide 3330, whendeployed, extends a distance from the central axis of the main shaftthat is less than or equal to the shortest distance of an exteriorsurface of the atraumatic tip to the central axis. Said another way, thedistal end of the side catheter guide 3330, when deployed, does notextend laterally beyond the exterior surface of the atraumatic tip whenviewed in side view.

Similarly, in any of the embodiments described herein, including, forexample, embodiments described without an atraumatic tip, the guidecoupler can be similarly disposed adjacent to the distal end of the sidecatheter guide such that the distal end of the side catheter guide, whendeployed, angularly deflects without substantial lateral deflection. Inthis manner, for example, in some implementations, when deployed, thedistal end of the side catheter guide may be disposed between thecentral axis of the main shaft and a line tangent the exterior surfaceof the main shaft when viewed in side view, such that deployment of theside catheter guide does not cause the distal end of the side catheterguide to increase the collective cross-sectional area of the sidecatheter guide and the main shaft. In some implementations, for example,the distal end of the side catheter guide, when deployed, is a distancefrom the central axis that is equal to or less than a radius of the mainshaft (the radius being the radius of the main shaft at or adjacent tothe guide coupler). In some implementations, for example, the distal endof the side catheter guide, when deployed, extends a lateral distancefrom the closest exterior surface of the main shaft of about less thanthe radius of the main shaft.

Although various atraumatic tips described herein are shown as acomponent and/or material that is formed separately and then coupled tothe main shaft, in some embodiments, the functionality of an atraumatictip (e.g., the atraumatic tip 3245) can be incorporated into andprovided by the main shaft. FIGS. 70A-70E illustrate a portion of aseptum puncture device, in various views, in a deployed configuration,according to such an embodiment.

Similar to other septum puncture devices described herein, the septumpuncture device 3400 can be used to access a left side of the heart(e.g., left atrium) from the right side of the heart (e.g., rightatrium) and to deliver a guidewire to the left side of the heart. Theseptum puncture device 3400 can be constructed the same as or similarto, and can function the same as or similar to, any of the septumpuncture devices described herein. Thus, portions of the septum puncturedevice 3400 are not described in further detail herein.

In this embodiment, the septum puncture device 3400 includes a mainshaft 3420 and a side catheter guide 3430 coupled to the main shaft 3420via a guide coupler 3440 (shown in FIGS. 70C-70E. A portion of the sidecatheter guide 3430 disposed proximal to the guide coupler 3420 isslidably disposed within a lumen defined by the main shaft 3420, and aportion of the side catheter guide 3430 disposed distal to the guidecoupler is disposed within and deflectable relative to the lumen of themain shaft 3420. Slidably disposed within the side catheter guide 3430is a side catheter 3460, and slidably disposed within the side catheter3460 is a septum penetrator 3460 (as shown in FIGS. 70A and 70B).Although not shown in this embodiment, as can be the case in any of theembodiments described herein, in some implementations, the septumpuncture device (e.g., including the septum puncture device 3400) caninclude an end effector (e.g., similar to or the same as in form and/orfunction as any of the end effectors described herein). As shown best inFIG. 70B, the main shaft 3420 defines a first slot 3446A and a secondslot 3446B (both of which are in communication with the lumen of themain shaft 3420). During deployment, the side catheter guide 3430 candeflect and extend through and beyond the first slot 3446A and thesecond slot 3446B, similar to as described above with respect to theseptum puncture device 3200 and the septum puncture device 3330.

The main shaft 3420 further includes a guide coupler coupler 3446C thatis configured to promote coupling between the guide coupler 3440 and themain shaft 3420. In this embodiment, the guide coupler coupler 3446C isformed of two apertures defined within the main shaft 3420 andconfigured to receive a portion of the guide coupler 3446 (see e.g.,FIG. 70C). In this manner, the side catheter guide 3430 can be securedto the main shaft 3420 via the guide coupler 3446, such that relativerotational movement between the main shaft 3420 and the side catheterguide 3420 is promoted, but relative translational movement between thesame is limited or prevented.

Various embodiments described herein include a side catheter guidedisposed adjacent and coupled to the main shaft via the guide coupler,however, it should be understand that any of these embodiments could bemodified such that side catheter guide is disposed within a lumendefined by the main shaft (e.g., either through the guide wire couplerdefined by or associated with the main shaft, or through a separatelumen defined by the main shaft). In such modified embodiments, the mainshaft can define slots and/or apertures through which the side catheterguide can extend or traverse during deployment of the side catheterguide.

Various configurations and methods of using septum puncture devices forpuncturing one or more holes through an atrial septum have beendescribed herein. In some instances it may be desirable to verify that apuncture in fact was performed in the desired location, e.g., to verifycommunication with the left atrium, and verify an establishedcommunication lumen between the left atrium and outside the patient'sbody via the septum penetrator. For example, it may be desirable toidentify an errant puncture (e.g., in an aorta or interatrial tissue)while the puncture is relatively small (e.g., before dilating the hole).

Once communication is established between the target region (e.g., theleft atrium) and outside the patient via the lumen defined by the septumpenetrator that has been extended into the left atrium, a variety ofverification techniques can be used. For example, one or more of thefollowing verification techniques can be used: measuring a pressurewithin the septum penetrator lumen, withdrawing a blood sample throughthe septum penetrator lumen, injecting through the septum penetratorlumen a contrast agent configured to be visible by an imaging modalitysuch as fluoroscopy and/or echocardiography, and/or the like.

In some implementations in which verification is desired, there aremultiple competing design goals. A first goal is clearly to provide acommunication lumen from outside the patient to the target region (e.g.,the left atrium). This goal can be accomplished, as described in variousembodiments here, by providing a septum penetrator with a lumen definedtherein. A second goal is to limit the cross-sectional area and/oroverall profile of the septum penetrator and thereby the hole that itcreates. This goal can be accomplished by closely matching the outerdiameter of the guidewire to be inserted into the left atrium with theinner diameter of the septum penetrator such that no, or close to no,annular gap exists between the internal surface of the septum penetratorand the exterior surface of the guidewire. A third goal is to preloadthe guidewire so as to minimize the time period required for theguidewire to be inserted into left atrium following the puncture. Saidanother way, with the guidewire preloaded or disposed within the septumpenetrator lumen before the septum penetrator lumen punctures the FO,the remaining distance needed for the guidewire to travel to reach theleft atrium is less than if the guidewire were first introduced into theseptum penetrator lumen after the septum penetrator punctures the FO.

With those goals in mind, in some embodiments, it is desirable to designa septum penetrator having a lumen of varying diameter such that anannular gap between the external surface of the guidewire and theinternal surface of the septum penetrator can be provided while stillpreloading the guidewire and keeping the septum penetrator diameter to aminimum.

FIGS. 71A-71D are schematic illustrations of a portion of a septumpenetrator of a septum puncture member 3500, according to such anembodiment. Similar to other septum puncture devices described herein,the septum puncture device 3500 can be used to access a left side of theheart (e.g., left atrium) from the right side of the heart (e.g., rightatrium) and to deliver a guidewire to the left side of the heart. Theseptum puncture device 3500 can be constructed the same as or similarto, and can function the same as or similar to, any of the septumpuncture devices described herein. Thus, portions of the septum puncturedevice 3500 are not described in further detail herein.

As shown in FIGS. 71A and 71B in cross-sectional side view and in sideview in line form, respectively, the septum puncture member 3500includes a septum penetrator 3560 that defines a lumen therethrough. Inthis embodiment, the septum penetrator 3560 is divided into threesegments, including a first segment L1, a second segment L2, and a thirdsegment L3. At the distal end of the septum penetrator 3560 is the sharpend portion of the septum penetrator 3560 that is configured to puncturethe target tissue (e.g., the FO of the septum). This sharp end portiondefines the first segment L1 with little to no annular gap between itsinner diameter and the external diameter of the guidewire, while thesharp end portion has a wall thickness strong enough to maintain enoughrigidity to suitably puncture the septum. The second segment L2 isdisposed immediately proximal to the first segment L1 and has an innerdiameter greater than the external diameter of the guidewire GW2 therebyproviding an annular gap between its inner wall and an external surfaceof the guidewire GW2. Further, the second segment L2 is sufficientlyflexible to assume a curved orientation as defined by the side catheter(not shown) within which it is slidably disposed when deflected with theside catheter guide (not shown). Further, the second segment L2 isconfigured to have a length sufficient to extend the entire curveddistance. The third segment L3 is disposed immediately proximal to thesecond segment L2, and also has an inner diameter greater than theexternal diameter of the guidewire GW2, but does not necessarily havethe same characteristics (e.g., flexibility, material, etc.) as thesecond segment L2. The third segment L3 has a length sufficient toextend proximally from the second segment L2, when the second segment L2is disposed within the heart of the patient, to outside the patient(e.g., and coupled to a handle).

FIG. 71C illustrates in cross-sectional side view the septum penetrator3560 having the guidewire GW2 preloaded in the third segment L3, withthe distal end of the guidewire GW2 terminating within the third segmentL3, and FIG. 71D illustrates in cross-sectional side view the septumpenetrator 3560 with the guidewire GW2 extending distally relative tothe preloaded position and distal to the septum penetrator 3560. Asdescribed in various embodiments, in use, with the guidewire GW2delivered distally from the septum penetrator 3560 and into the leftatrium, the septum penetrator 3560 can then be withdrawn proximallyrelative to the guidewire GW2, leaving the guidewire GW2 disposed withinthe left atrium. In the context of this embodiment, referring to FIG.71C in which the distal end of the guidewire GW2 is disposed proximal tothe first segment L1, the proximal end of the septum penetrator 3560 isin fluid communication with the distal end portion of the septumpenetrator (e.g., the first segment L1 and the second segment L2) viaits lumen, such that the verification techniques described herein can beemployed using the lumen. For example, in some instances, a contrastagent can be introduced into the lumen of the septum penetrator 3560 atits proximal end (e.g., from outside the patient) and conveyed aroundthe guidewire GW2 (i.e., within the annular gap defined between theinner surface of the septum penetrator 3560 and the exterior surface ofthe guidewire GW2), through and out of the distal end of the septumpenetrator 3560, and into the left atrium, whereby the contrast agentcan be viewed via fluoroscopy, and/or similar imaging modalities. Afterverification, the annular gap is no longer needed, and so the guidewireGW2 can then be extended distally relative to the septum penetrator 3560and delivered to the left atrium.

Although the guidewire GW2 is shown preloaded into the third segment L3,but proximal to the second segment L2, in other implementations, theguidewire GW2 can be preloaded into the second segment L2, but proximalto the first segment L2, such that fluid communication is similarlyprovided from the first segment L1, proximally through the secondsegment L2 and the third segment L3, and further proximally through theseptum penetrator 3560 and out the patient, e.g., and to a handleassembly (not shown).

Although the septum penetrator 3560 is shown and described as havingthree segments, in some embodiments, the septum penetrator 3560 can haveany suitable number of segments (e.g., one segment, two segments, ormore than three segments). For example, in some embodiments, themost-distal segment of the septum penetrator can have a first lumenhaving a first diameter, and a second segment proximal to themost-distal segment can have a second lumen having a second diametergreater than the first diameter. In this manner, similar to as describedwith respect to the septum penetrator 3560 and the guidewire GW2, aguidewire can be disposed within the second lumen and upstream the firstlumen, thereby providing fluidic communication between the first lumenand the second lumen, and hence to outside the patient (e.g. via ahandle assembly to which a proximal end portion of the septum penetratoris coupled).

In some embodiments, instead of or in addition to a septum penetratorhaving variable lumen diameters, the septum penetrator can includemultiple distinct or partially distinct lumens. In such embodiments, forexample, the septum penetrator can have two distinct lumens extendingacross the entire septum penetrator; one designated for the guidewireand the other designated for fluidic communication for purposes ofverification, as described in further detail herein. As another example,the septum penetrator can have a single lumen extending proximally fromits most-distal end, and then bifurcate into two lumens, one of whichcan be designated for the guidewire and the other of which can bedesignated for fluidic communication for purposes of verification. Inthis manner, in use, the guidewire can be preloaded within one of thebifurcated lumens when the septum penetrator punctures the septum, averification technique can be employed via the other bifurcated lumen,and then the guidewire can be advanced distally into the single lumenand delivered distally from the septum penetrator and into the leftatrium (or other target region).

FIGS. 72A and 72B illustrate a portion of a septum puncture device 3600in a delivery configuration in side view and perspective view,respectively, according to an embodiment.

Similar to other septum puncture devices described herein, the septumpuncture device 3600 can be used to access a left side of the heart(e.g., left atrium) from the right side of the heart (e.g., rightatrium) and to deliver a guidewire to the left side of the heart. Theseptum puncture device 3600 can be constructed the same as or similarto, and can function the same as or similar to, any of the septumpuncture devices described herein. Thus, portions of the septum puncturedevice 3600 are not described in further detail herein.

In this embodiment, the septum puncture device 3600 includes a mainshaft 3620 and a side catheter guide 3630 coupled to the main shaft 3620via a guide coupler 3640, similar to as described in connection withother embodiments. The septum puncture device 3600 further includes anatraumatic tip 3645 coupled to and disposed about the main shaft 3620,and slightly axially offset from a distal end portion of the sidecatheter guide 3030 when the side catheter guide 3030 is in the deliveryconfiguration. As shown in FIG. 72A, the distal end of the side catheterguide 3630 is shielded or at least partially covered by the atraumatictip 3645. In this manner, during insertion of the septum puncture device3600 into the patient, with the side catheter guide 3630 in its deliveryconfiguration, the atraumatic tip 3645 protects the patient'svasculature and associated anatomy from inadvertent trauma from the sidecatheter guide 3630. When deployed (not shown), the distal end of theside catheter guide 3630 is angularly deflected relative to the mainshaft 3620, as described in some embodiments herein, such that a sidecatheter (not shown) can then be extended distally therethrough. Asshown, in this embodiment, the collective cross-sectional area of themain shaft 3620 and the side catheter guide 3630 is less than thecross-sectional area of the atraumatic tip 3645 at its proximal end(i.e., it's maximum cross-sectional area), such that the atraumatic tip3645 shields the distal end portion of the side catheter guide 3630.Said another way, when viewed in front view, the side catheter guide3645 is not visible, as its profile is smaller than the profile of theatraumatic tip 3645.

Further, in this embodiment, the atraumatic tip 3645 has an asymmetricshape such that during delivery, as shown in FIG. 72A, the atraumatictip 3645 shields the entire distal end of the side catheter guide 3630,while limiting the overall footprint of the atraumatic tip 3645. Morespecifically, in this embodiment, the atraumatic tip 3645 reduces incross-sectional area from its proximal end to its distal end.

Further, the atraumatic tip 3645 includes a radiopaque (e.g.,fluoroscopic) marker band 3646 disposed circumferentially about anexterior surface of the atraumatic tip 3645. The atraumatic tip 3645defines a grove on which the radiopaque marker band 3646 is disposedsuch that the band 3646 does not increase the overall profile,cross-sectional area, and/or diameter of the remaining portion of theatraumatic tip 3645.

In some embodiments, a needle can be aimed at a specific region of theFO for puncture. The FO can be divided into quadrants, for example, inwhich a puncture in each quadrant is advantageous for a specificprocedure. The needle can thereby be aimed to puncture slightlysuperior, posterior, and 3.5 cm-4.5 cm above the mitral valve for aMitraClip device, or to puncture posterior and slightly inferior withinthe FO for typical left atrial appendage occlusion devices. Aftersuccessful puncture and insertion of a guidewire, the septum puncturedevice can be completely removed to make way for any suitable instrumentor device to be guided into the left atrium of the heart to perform adesired procedure, such as atrial fibrillation ablation, left atrialappendage closure, and valve replacements.

Various embodiments described herein include a side catheter guideconfigured to transition from a delivery configuration to a deployedconfiguration in response to a distal force applied to a portion of theside catheter guide that is disposed proximal to the guide coupler(e.g., a distal force applied at the handle). In some implementations ofsuch embodiments described herein, instead of or in addition to suchdistal force, a proximal force can be applied to the main shaft (e.g.,proximal the guide coupler) to cause similar deployment of the sidecatheter guide. Said another way, deployment of the side catheter guidecan be accomplished merely by relative movement between the main shaftand the side catheter guide, which can include a proximal force appliedto the main shaft and/or a distal force applied to the side catheterguide.

In various embodiments described herein, a side catheter guide isdeflected such that a distal end portion of the side catheter guideangularly and/or laterally deflects about 90 degrees relative to acentral axis of a main shaft to which the side catheter guide iscoupled. In any of the embodiments described herein, in someimplementations, such deflection can be greater than or less than 90degrees. In such implementations, the deflection may be less than lessthan about 90 degrees, such as, for example, about 15 degrees, about 30degrees, about 45 degrees, about 60 degrees, about 75 degrees, or anydegrees therebetween. In some implementations, the deflection may beabout 75 degrees to about 85 degrees, e.g., about 80 degrees. In evenfurther implementations, the deflection may be greater than about 90degrees, such as, for example, about 95 degrees, about 105 degrees,about 110 degrees, about 115 degrees, about 120 degrees, about 135degrees, or any degrees therebetween. In yet further implementations,the deflection may be from about 50 degrees to about 90 degrees.

In various embodiments described herein, a side catheter guide isdeflected such that a distal end portion of the side catheter guideangularly and/or laterally deflects relative to a central axis of the amain shaft to which the side catheter guide is coupled (and/or relativeto a target tissue, such as an atrial septum). In any of the embodimentsdescribed herein, in some implementations, deflection of the sidecatheter guide can be operator-selectable, meaning that an operator ofthe septum puncture device can select a particular amount or angle ofdeflection from among multiple available amounts or angles ofdeflection. In such implementations, for example, a side catheter guidecan be configured to deflect a first amount or angle and a different,second amount or angle, such that an operator can selectively deflectthe side catheter guide as desired (e.g., based on a particularpatient's anatomy, and/or the particular procedure(s) being performed).In this manner, a septum puncture device can have multiple deployedconfigurations, each having varying amounts/angles of deflection.

Further, in some embodiments, the deflection selected by the operatorcan be subsequently fixed and/or temporarily locked in place, such thatthe selected deflection remains during subsequent steps, such as, forexample, distal extension of a side catheter and/or puncture member, andsubsequent puncture of the target tissue. Such fixation can be employedin any suitable manner. As an example, a proximal end portion of theside catheter guide can be slidably fixed (e.g., to a body and/or ahandle assembly).

Various embodiments described herein include a GSA or balloon configuredto transition between a delivery configuration and a deployedconfiguration. In some implementations of any of the embodimentsdescribed herein, one or more GSAs or balloons can be covered partiallyor completely with a mesh made from any suitable material (e.g., nylon,polymer, etc.). The mesh, coupled to a balloon, for example, canfacilitate a preferred, predefined shape of the balloon when inflated,or can facilitate the step or steps of inflating the balloon by, e.g.,providing additional stability. An example illustrate of a mesh coveringa balloon is illustrated in FIG. 64 which shows a GSA 2950 covered witha mesh GSA 2955, both of which are disposed circumferentially about amain shaft 2920. In some embodiments, the mesh can be used for securing(slidably or fixedly) the balloon(s) to a side catheter guide or a sidecatheter.

Although various embodiments described herein focus on using a puncturedevice to puncture a septum of a heart, the functionality provided byvarious puncture devices described herein can be desirable in otherprocedures and in other parts of a patient. For example, many proceduresexist in which it would be desirable to be able to provide a stable,precise, safe, and repeatable lateral puncture. In some instances, forexample, any of the puncture devices described herein could be used tofacilitate a tricuspid annuloplasty. The puncture device, for example,could be arrange such that a central axis of its main shaft is parallelto a plane of the tricuspid valve, and so the puncture device couldprovide lateral or perpendicular access to the annulus of the tricuspid,e.g., to deliver sutures, screws, or other anchoring devices forpurposes of a tricuspid annuloplasty.

As another example, the puncture devices described herein could providea access and a direct vector to a coronary sinus of a heart, to, e.g.,insert or deliver a wire, a catheter, a mitral valve repair device,pacemaker leads, etc. into the coronary sinus.

As another example, the puncture devices described herein could be usedfor delivering therapeutic repair or replacement devices to a mitralvalve within a heart. If, for example, a side catheter guide or a sidecatheter disclosed herein were extended further, and beyond about 90degrees, the side catheter could be directed into the LA and towards themitral valve. In some instances, the natural trajectory of the sidecatheter in some of the embodiments described herein would be angled ordirected towards the mitral valve if extended or advanced a suitabledistance. For example, as the side catheter assumes its laterallydeflected shape or orientation, it may be curved or possess an arc, suchthat further advancement relative to the main shaft results in the sidecatheter advancing along such a curvature or arc such that the distalend of the side catheter turns or is further laterally deflected towardsthe mitral valve. Said another way, in some instances, advancement ofthe side catheter from its delivery configuration to anadvanced/deployed configuration can include the distal end of the sidecatheter being laterally deflected up to about 180 degrees.

As another example, the puncture devices described herein couldincorporate an intracardiac echo catheter to enable acceleratetransseptal puncture.

As another example, the puncture devices described herein could be usedin connection with cardiac arrest. In such instances, for example, oneor more puncture devices could be used in combination with a broad,curved catheter, to enable a guide wire to be directed or delivered fromthe femoral vein, across the FO, through the mitral valve and out theleft ventricular outflow tract (“LVOT”)/aortic valve. In someembodiments a balloon/flow-directed catheter would be advanced acrossthe FO, into the LA, across the mitral valve and then across theLVOT/aortic valve; the balloon, for example, would serve to “flowdirect” the catheter out the LVOT and across the aortic valve into theaorta. Once in position, the wire could be used as a track for a smallcatheter that could provide extracorporeal membrane oxygenation (“ECMO”)and oxygen to the brain. A distal end of the catheter in the aorta wouldbe the outflow, and more proximal ports (e.g., in the RA or the IVC)would be the inflow to the pump.

As another example, the puncture devices described herein could be usedin an aorta to facilitate delivery of branch vessel stents, to delivercoils to branch vessels, or to deliver a screen for cerebral embolicprotection to the head vessel.

Detailed embodiments of the present disclosure have been disclosedherein or purposes of describing and illustrating claimed structures andmethods that can be embodied in various forms, and are not intended tobe exhaustive in any way, or limited to the disclosed embodiments. Manymodifications and variations will be apparent without departing from thescope of the disclosed embodiments. The terminology used herein waschosen to best explain the principles of the one or more embodiments,practical applications, or technical improvements over currenttechnologies, or to enable understanding of the embodiments disclosedherein. As described, details of well-known features and techniques canbe omitted to avoid unnecessarily obscuring the embodiments of thepresent disclosure.

References in the specification to “one embodiment,” “an embodiment,”“an example embodiment,” or the like, indicate that the embodimentdescribed can include one or more particular features, structures, orcharacteristics, but it shall be understood that such particularfeatures, structures, or characteristics may or may not be common toeach and every disclosed embodiment disclosed herein. Moreover, suchphrases do not necessarily refer to any one particular embodiment perse. As such, when one or more particular features, structures, orcharacteristics is described in connection with an embodiment, it issubmitted that it is within the knowledge of those skilled in the art toaffect such one or more features, structures, or characteristics inconnection with other embodiments, where applicable, whether or notexplicitly described.

Parameters, dimensions, materials, and configurations described hereinare meant to be examples and that the actual parameters, dimensions,materials, and/or configurations will depend upon the specificapplication or applications for which the inventive teachings is/areused. It is, therefore, to be understood that the foregoing embodimentsare presented by way of example only and that, within the scope of theappended claims and equivalents thereto; and that embodiments can bepracticed otherwise than as specifically described and claimed.Embodiments of the present disclosure are directed to each individualfeature, system, article, material, kit, and/or method described herein.In addition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the scope of the present disclosure.

As you herein, the phrase “and/or” should be understood to mean “eitheror both” of the elements so conjoined, i.e., elements that areconjunctively present in some cases and disjunctively present in othercases. Multiple elements listed with “and/or” should be construed in thesame fashion, i.e., “one or more” of the elements so conjoined. Otherelements may optionally be present other than the elements specificallyidentified by the “and/or” phrase, whether related or unrelated to thoseelements specifically identified. Thus, as a non-limiting example, areference to “A and/or B”, when used in conjunction with open-endedlanguage such as “comprising” or “including” can refer, in oneembodiment, to A only (optionally including elements other than B); inanother embodiment, to B only (optionally including elements other thanA); in yet another embodiment, to both A and B (optionally includingother elements); etc.

As used herein, the term, “or” should be understood to have the samemeaning as “and/or” as defined above. For example, when separating itemsin a list, “or” or “and/or” shall be interpreted as being inclusive,i.e., the inclusion of at least one, but also including more than one,of a number or list of elements, and, optionally, additional unlisteditems. Only terms clearly indicated to the contrary, such as “only oneof” or “exactly one of,” or, when used in the claims, “consisting of,”will refer to the inclusion of exactly one element of a number or listof elements. In general, the term “or” as used herein shall only beinterpreted as indicating exclusive alternatives (i.e. “one or the otherbut not both”) when preceded by terms of exclusivity, such as “either,”“one of,” “only one of,” or “exactly one of.” “Consisting essentiallyof,” when used in the claims, shall have its ordinary meaning as used inthe field of patent law.

As used herein, the terms “about” and/or “approximately” when used inconjunction with values and/or ranges generally refer to those valuesand/or ranges near to a recited value and/or range. In some instances,the terms “about” and “approximately” may mean within ±10% of therecited value. For example, in some instances, “approximately a diameterof an instrument” may mean within ±10% of the diameter of theinstrument. The terms “about” and “approximately” may be usedinterchangeably. Similarly, the term “substantially” when used inconjunction with physical and/or geometric feature(s), structure(s),characteristic(s), relationship(s), etc. is intended to convey that thefeature(s), structure(s), characteristic(s), relationship(s), etc. sodefined is/are nominally the feature(s), structure(s),characteristic(s), relationship(s), etc. As one example, a firstquantity that is described as being “substantially equal” to a secondquantity is intended to convey that, although equality may be desirable,some variance can occur. Such variance can result from manufacturingtolerances, limitations, approximations, and/or other practicalconsiderations. Thus, the term “substantially.”

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where schematics and/or embodiments described above indicatecertain components arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Although variousembodiments have been described as having particular features and/orcombinations of components, other embodiments are possible having acombination of any features and/or components from any of embodimentsdescribed herein.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different from the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired or intended usage. Thus, it should be understood that the size,shape, and/or arrangement of the embodiments and/or components thereofcan be adapted for a given use unless the context explicitly statesotherwise.

Where methods and/or events described above indicate certain eventsand/or procedures occurring in certain order, the ordering of certainevents and/or procedures may be modified. Additionally, certain eventsand/or procedures may be performed concurrently in a parallel processwhen possible, as well as performed sequentially as described above.

The invention claimed is:
 1. An apparatus, comprising: a shaft; a guidecoupled and angularly deflectable relative to the shaft via a guidecoupler, the guide configured to be transitioned between a deliveryconfiguration and a deployed configuration in which a distal end of theguide points away from a centerline of the shaft when transitioned fromits delivery configuration to its deployed configuration, the guidedefining a lumen; an elongate member slidably disposable within thelumen of the guide and configured to extend distally relative to theguide, the elongate member defining a lumen; an atraumatic end effectorextending from a distal end portion of the elongate member, the endeffector being configured to transition between a delivery configurationin which the end effector has a first cross-sectional area and adeployed configuration in which the end effector has a secondcross-sectional area greater than the first cross-sectional area, thesecond cross-sectional area configured to be smaller in diameter than afossa of a patient such that the end effector when in the deployedconfiguration can be applied against a particular region within thefossa to tent a target puncture site of the patient, the end effectorbeing configured to assume the delivery configuration when constrainedwithin the lumen of the guide, and self-transition to its deployedconfiguration as it exits the lumen of the guide and assumes anunconstrained form; and a puncture member slidably disposable within thelumen of the elongate member and configured to extend distally relativeto the distal end portion of the elongate member, the puncture memberbeing configured to puncture the target puncture site.
 2. The apparatusof claim 1, wherein: the puncture member defines a lumen configured toslidably receive a guide wire.
 3. The apparatus of claim 1, wherein: theguide coupler allows rotational movement of the guide relative to theshaft and limits relative linear movement between the guide coupler andthe guide.
 4. The apparatus of claim 1, wherein: the guide extendsproximally from its distal end across at least a portion of the shaft,and beyond a side of the shaft, and then turns and extends proximallytowards a proximal end of the shaft, when the guide is in its deployedconfiguration and the elongate member is at least partially disposedwithin the lumen of the guide.
 5. The apparatus of claim 1, furthercomprising: a handle operably coupled to the shaft and the guide, theshaft and the guide extending distally from the handle, a length of theguide disposed between a distal end of the handle and the guide couplerincreases in response to the guide being transitioned from its deliveryconfiguration to its deployed configuration.
 6. The apparatus of claim1, wherein: the guide coupler is spaced proximally from a distal end ofthe shaft.
 7. The apparatus of claim 1, wherein: the shaft defines atleast one lumen of the shaft, the at least one lumen configured toreceive a guide wire.
 8. The apparatus of claim 1, wherein: the guide isconfigured to be transitioned between its delivery configuration and itsdeployed configuration in response to relative movement between (1) aportion of the guide disposed proximal to the guide coupler and (2) theshaft.
 9. The apparatus of claim 1, wherein the elongate member is aside catheter, and the guide is a side catheter guide.
 10. The apparatusof claim 1, wherein the guide coupler is disposed within a lumen definedby the shaft.
 11. The apparatus of claim 1, wherein the puncture memberdefines a lumen configured to slidably receive a guide wire, the lumenof the puncture member having a first internal diameter at a distal endportion thereof and a second internal diameter, greater than the firstinternal diameter, in a portion proximal to the distal end portion ofthe lumen of the puncture member.
 12. The apparatus of claim 1, whereinthe shaft has an atraumatic distal end.
 13. The apparatus of claim 1,wherein the shaft has a tapered atraumatic distal end.
 14. The apparatusof claim 1, wherein the end effector is formed of shape-memory material.15. The apparatus of claim 14, wherein the end effector is formed ofNitinol.
 16. An apparatus, comprising: a shaft; a guide coupled andangularly deflectable relative to the shaft, the guide configured to betransitioned between a delivery configuration and a deployedconfiguration in which a distal end of the guide points away from acenterline of the shaft when transitioned from its deliveryconfiguration to its deployed configuration, the guide defining a lumen;an elongate member slidable relative to the guide and configured toextend distally relative to the guide, the elongate member defining alumen; an atraumatic end effector extending from a distal end portion ofthe elongate member, the end effector being configured to transitionbetween a delivery configuration in which the end effector has a firstcross-sectional area and a deployed configuration in which the endeffector has a second cross-sectional area greater than the firstcross-sectional area, the second cross-sectional area configured to besmaller in diameter than a fossa of a patient such that the end effectorwhen in the deployed configuration can be applied to the fossa to tent atarget puncture site of the patient, the end effector configured to beconstrained in its delivery configuration when disposed within the lumenof the guide, and self-expand as it exits the lumen of the guide; and apuncture member slidably disposable within the lumen of the elongatemember and configured to extend distally relative to the distal endportion of the elongate member, the puncture member being configured topuncture the target puncture site.
 17. The apparatus of claim 16,wherein the puncture member defines a lumen configured to slidablyreceive a guidewire.
 18. The apparatus of claim 16, further comprising aguide coupler, the guide being coupled to the shaft via the guidecoupler, wherein the guide coupler is spaced proximally from a distalend of the shaft.
 19. The apparatus of claim 16, wherein the elongatemember is a side catheter, and the guide is a side catheter guide. 20.The apparatus of claim 16, wherein the shaft has a tapered atraumaticdistal end.
 21. The apparatus of claim 16, wherein the distal endportion of the elongate member is a distal-most end of the elongatemember.
 22. The apparatus of claim 16, wherein the end effector isformed of shape-memory material.
 23. The apparatus of claim 16, whereinthe end effector is formed of Nitinol.
 24. The apparatus of claim 16,wherein the elongate member is slidably disposable within a lumendefined by the shaft.